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Patient Centered-Rehabilitation ver111090.1 (PCN1)

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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

Brief Summary:
As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.

Condition or disease Intervention/treatment Phase
Cognitive Change Device: Active HD-tDCS Device: Sham HD-tDCS Not Applicable

Detailed Description:

The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.

Tolerability and blinding will also be evaluated using standard side effect questionnaires.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Active HD-tDCS
Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.
Device: Active HD-tDCS
Participants will receive active HD-tDCS at 3mA for 20 minutes
Other Name: HD-tDCS

Sham Comparator: Sham HD-tDCS
Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.
Device: Sham HD-tDCS
Participants will receive sham HD-tDCS




Primary Outcome Measures :
  1. Object Location Touchscreen Task (Version C) Free Recall Total Error [ Time Frame: 15 minutes after encoding ]
    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.

  2. Object Location Touchscreen Task (Version C) Free Recall Average Error [ Time Frame: 15 minutes after encoding ]
    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.

  3. Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond [ Time Frame: 15 minutes after encoding ]
    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.

  4. Object Location Touchscreen Task (Version C) Cued Recall Total Error [ Time Frame: 15 minutes after encoding ]
    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.

  5. Object Location Touchscreen Task (Version C) Cued Recall Average Error [ Time Frame: 15 minutes after encoding ]
    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.

  6. Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond [ Time Frame: 15 minutes after encoding ]
    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.

  7. Object Location Touchscreen Task (Version C) Recognition Total Correct [ Time Frame: 15 minutes after encoding ]
    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.

  8. Object Location Touchscreen Task (Version C) Recognition Average Time to Respond [ Time Frame: 15 minutes after encoding ]
    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.

  9. Performance (d') on a Simple Attention (0-back) Test [ Time Frame: 30 minutes post-stimulation ]
    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.

  10. Performance (d') on a Working Memory (2-back) Test [ Time Frame: 30 minutes post-stimulation ]
    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.

  11. Performance (d') on a Working Memory (Semantic 2-back) Test [ Time Frame: 30 minutes post-stimulation ]
    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.

  12. Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d') [ Time Frame: 30 minutes post-stimulation ]
    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.

  13. Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d') [ Time Frame: 30 minutes post-stimulation ]
    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.


Secondary Outcome Measures :
  1. Blinding in Total Sample [ Time Frame: ~1 minute post stimulation ]
    Participants were asked to estimate which group they were in (i.e., active or sham).

  2. Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  3. Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  4. Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  5. Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  6. Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  7. Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  8. Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  9. Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  10. Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".

  11. Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session [ Time Frame: ~1 minute post stimulation ]
    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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Individuals with intact cognitive functioning.
  2. Participants will be age 50 or older.

Exclusion Criteria:

  1. Individuals with a documented history of cognitive impairment.
  2. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
  3. Sensory or motor impairments that limit the ability to take part in the study
  4. A significant history or current use of alcohol or drug abuse/dependence
  5. Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
  6. Participants with an Mini Mental State Examination score <24 at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034954


Locations
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United States, Michigan
University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Benjamin M Hampstead, PhD University of Michigan
  Study Documents (Full-Text)

Documents provided by Benjamin Hampstead, PhD, University of Michigan:

Publications:
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Responsible Party: Benjamin Hampstead, PhD, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03034954     History of Changes
Other Study ID Numbers: HUM00111090.1 PCN
First Posted: January 27, 2017    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No