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Patient Centered-Rehabilitation ver111090.1 (PCN1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034954
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Hampstead, PhD, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cognitive Change
Interventions Device: Active HD-tDCS
Device: Sham HD-tDCS
Enrollment 42
Recruitment Details  
Pre-assignment Details Two participants were excluded after consent due to failing the tDCS safety screen. One participant endorsed a skin condition with lesions at site of electrode placement. One participant disclosed a prior head injury.
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Period Title: Overall Study
Started 21 21
Completed 20 21
Not Completed 1 0
Reason Not Completed
Machine malfunction; did not reach 3 mA             1             0
Arm/Group Title Active HD-tDCS Sham HD-tDCS Total
Hide Arm/Group Description

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Total of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
One participant was a statistical outlier for several behavioral measures and was excluded from baseline data and all analyses
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
66.42  (8.546) 65.38  (10.604) 65.88  (9.573)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
11
  57.9%
16
  76.2%
27
  67.5%
Male
8
  42.1%
5
  23.8%
13
  32.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
21
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
1
   2.5%
Native Hawaiian or Other Pacific Islander
1
   5.3%
0
   0.0%
1
   2.5%
Black or African American
0
   0.0%
1
   4.8%
1
   2.5%
White
18
  94.7%
19
  90.5%
37
  92.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 21 participants 40 participants
19
 100.0%
21
 100.0%
40
 100.0%
Mini-Mental State Examination   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
28.58  (1.216) 28.37  (1.212) 28.47  (1.202)
[1]
Measure Description: The Mini Mental-State Examination is a 30-item global cognitive screen. Scores range from 0-30 with higher scores represent better performances and scores 23 and below are suggestive of cognitive impairment.
[2]
Measure Analysis Population Description: Participants were not screened if an MMSE was completed within the past six months as part of their involvement with the Michigan Alzheimer's Disease Center (n = 2)
Education   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 21 participants 38 participants
16.82  (1.59) 16.48  (2.089) 16.63  (1.866)
[1]
Measure Analysis Population Description: Missing data for two participants
Impedance   [1] 
Mean (Standard Deviation)
Unit of measure:  Quality units
Number Analyzed 19 participants 21 participants 40 participants
0.9512  (0.4004) 0.8939  (.06314) 0.921  (0.528)
[1]
Measure Description: The first impedance reading averaged across all five electrodes. The unit measured is in "Quality Units" as produced by the Soterix transcranial direct current stimulation machine, which is a proprietary measurement of impedance. Lower values represent less impedance.
Object Location Touchscreen Task (Version B) Free Recall Total Error   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 19 participants 21 participants 40 participants
115.27  (44.445) 102.534  (6.835) 108.583  (7.239)
[1]
Measure Description: The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version B) Free Recall Average Error   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 19 participants 21 participants 40 participants
7.685  (2.963) 6.835  (2.97) 7.239  (2.96)
[1]
Measure Description: The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version B) Free Recall Average Time to Respond   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 19 participants 21 participants 40 participants
3796.361  (1188.015) 4921.558  (2306.631) 4387.09  (1924.503)
[1]
Measure Description: The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Object Location Touchscreen Task (Version B) Cued Recall Total Error   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 19 participants 21 participants 40 participants
74.513  (51.385) 45.055  (38.61) 59.048  (46.958)
[1]
Measure Description: The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version B) Cued Recall Average Error   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 19 participants 21 participants 40 participants
4.971  (3.422) 3.002  (2.574) 3.937  (3.129)
[1]
Measure Description: The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version B) Cued Recall Average Time to Respond   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 19 participants 21 participants 40 participants
3855.83  (2452.1) 3307.879  (1605.689) 3568.155  (2043.063)
[1]
Measure Description: The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Object Location Touchscreen Task (Version B) Recognition Total Correct   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of correct answers
Number Analyzed 19 participants 21 participants 40 participants
13.11  (1.941) 14.05  (1.322) 13.6  (1.692)
[1]
Measure Description: The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.
Object Location Touchscreen Task (Version B) Recognition Average Time to Respond   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 19 participants 21 participants 40 participants
3005.095  (1807.47) 2456.063  (1164.46) 2716.853  (1510.062)
[1]
Measure Description: The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
1.Primary Outcome
Title Object Location Touchscreen Task (Version C) Free Recall Total Error
Hide Description The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: centimeters
121.498  (26.366) 99.77  (27.845)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .300
Comments Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.
Method Repeated Measures ANOVA
Comments repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)
2.Primary Outcome
Title Object Location Touchscreen Task (Version C) Free Recall Average Error
Hide Description The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: centimeters
8.099  (1.757) 6.652  (1.856)
3.Primary Outcome
Title Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond
Hide Description The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: milliseconds
3419.878  (1690.354) 3029.648  (1572.416)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .044
Comments Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).
Method Repeated Measures ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Object Location Touchscreen Task (Version C) Cued Recall Total Error
Hide Description The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: centimeters
66.806  (29.303) 43.775  (29.32)
5.Primary Outcome
Title Object Location Touchscreen Task (Version C) Cued Recall Average Error
Hide Description The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: centimeters
4.453  (1.954) 2.919  (1.954)
6.Primary Outcome
Title Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond
Hide Description The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: milliseconds
3991.659  (2218.596) 2666.858  (866.887)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments [Not Specified]
7.Primary Outcome
Title Object Location Touchscreen Task (Version C) Recognition Total Correct
Hide Description The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: number of correct answers
12.79  (1.932) 13.45  (1.669)
8.Primary Outcome
Title Object Location Touchscreen Task (Version C) Recognition Average Time to Respond
Hide Description The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Time Frame 15 minutes after encoding
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: milliseconds
2804.459  (1244.249) 1903.39  (843.244)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments [Not Specified]
9.Primary Outcome
Title Performance (d') on a Simple Attention (0-back) Test
Hide Description The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Time Frame 30 minutes post-stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
missing data for two participants
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: d'
4.26  (.231) 4.25  (.219)
10.Primary Outcome
Title Performance (d') on a Working Memory (2-back) Test
Hide Description The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Time Frame 30 minutes post-stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
missing data for two participants
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: d'
3.05  (.508) 2.94  (.675)
11.Primary Outcome
Title Performance (d') on a Working Memory (Semantic 2-back) Test
Hide Description The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Time Frame 30 minutes post-stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: d'
1.518  (.537) 1.69  (.495)
12.Primary Outcome
Title Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')
Hide Description The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
Time Frame 30 minutes post-stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation & one 0-back (Active)
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: d'
-1.130  (.629) -1.31  (.675)
13.Primary Outcome
Title Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')
Hide Description The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
Time Frame 30 minutes post-stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
missing data for two participants
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: d'
-2.69  (.58) -2.56  (.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .450
Comments [Not Specified]
Method MANOVA
Comments [Not Specified]
14.Secondary Outcome
Title Blinding in Total Sample
Hide Description Participants were asked to estimate which group they were in (i.e., active or sham).
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
Said Active
9
  47.4%
6
  28.6%
Said Sham
9
  47.4%
8
  38.1%
Said Don't Know
1
   5.3%
7
  33.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .078
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
15.Secondary Outcome
Title Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
Headache NONE
19
 100.0%
18
  85.7%
Headache MILD
0
   0.0%
3
  14.3%
Headache MODERATE
0
   0.0%
0
   0.0%
Headache SEVERE
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .233
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
Neck Pain NONE
19
 100.0%
21
 100.0%
Neck Pain MILD
0
   0.0%
0
   0.0%
Neck Pain MODERATE
0
   0.0%
0
   0.0%
Neck Pain SEVERE
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
16
  84.2%
20
  95.2%
MILD
1
   5.3%
0
   0.0%
MODERATE
1
   5.3%
1
   4.8%
SEVERE
1
   5.3%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .600
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Secondary Outcome
Title Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
6
  31.6%
7
  33.3%
MILD
12
  63.2%
11
  52.4%
MODERATE
1
   5.3%
2
   9.5%
SEVERE
0
   0.0%
1
   4.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Secondary Outcome
Title Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
16
  84.2%
14
  66.7%
MILD
3
  15.8%
7
  33.3%
MODERATE
0
   0.0%
0
   0.0%
SEVERE
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .281
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
20.Secondary Outcome
Title Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
9
  47.4%
7
  33.3%
MILD
10
  52.6%
8
  38.1%
MODERATE
0
   0.0%
5
  23.8%
SEVERE
0
   0.0%
1
   4.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .082
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Secondary Outcome
Title Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
19
 100.0%
19
  90.5%
MILD
0
   0.0%
2
   9.5%
MODERATE
0
   0.0%
0
   0.0%
SEVERE
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .490
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
22.Secondary Outcome
Title Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
19
 100.0%
18
  85.7%
MILD
0
   0.0%
2
   9.5%
MODERATE
0
   0.0%
1
   4.8%
SEVERE
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .488
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
23.Secondary Outcome
Title Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
17
  89.5%
21
 100.0%
MILD
2
  10.5%
0
   0.0%
MODERATE
0
   0.0%
0
   0.0%
SEVERE
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active HD-tDCS, Sham HD-tDCS
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .219
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
24.Secondary Outcome
Title Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
Hide Description The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Time Frame ~1 minute post stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description:

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

Overall Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
NONE
19
 100.0%
21
 100.0%
MILD
0
   0.0%
0
   0.0%
MODERATE
0
   0.0%
0
   0.0%
SEVERE
0
   0.0%
0
   0.0%
Time Frame Adverse events data were collected for the duration of participation (i.e., approximately 2-3 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active HD-tDCS Sham HD-tDCS
Hide Arm/Group Description

Participants will receive “real” HD-tDCS (3 milliamps for 20 minutes) for a single session.

Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Sham HD-tDCS: Participants will receive sham HD-tDCS

All-Cause Mortality
Active HD-tDCS Sham HD-tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active HD-tDCS Sham HD-tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active HD-tDCS Sham HD-tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/19 (84.21%)      19/21 (90.48%)    
General disorders     
Headache   0/19 (0.00%)  0 3/21 (14.29%)  3
Neck Pain   0/19 (0.00%)  0 0/21 (0.00%)  0
Sleepiness   0/19 (0.00%)  0 3/21 (14.29%)  3
Concentration Changes   2/19 (10.53%)  2 0/21 (0.00%)  0
Psychiatric disorders     
Mood Changes   0/19 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Scalp Pain   3/19 (15.79%)  3 1/21 (4.76%)  1
Tingling   13/19 (68.42%)  13 14/21 (66.67%)  14
Itching   3/19 (15.79%)  3 7/21 (33.33%)  7
Burning sensation   10/19 (52.63%)  10 14/21 (66.67%)  14
Skin redness   0/19 (0.00%)  0 2/21 (9.52%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Annalise Rahman-Filipiak
Organization: University of Michigan
Phone: 734-763-9259
Responsible Party: Benjamin Hampstead, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT03034954     History of Changes
Other Study ID Numbers: HUM00111090.1 PCN
First Submitted: October 24, 2016
First Posted: January 27, 2017
Results First Submitted: May 18, 2018
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018