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NMDA Receptors in Motor Learning in Humans

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ClinicalTrials.gov Identifier: NCT02082912
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : April 22, 2015
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Butler, PhD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: D-cycloserine
Other: Placebo
Device: HandMentor Pro
Enrollment 14
Recruitment Details Participants were recruited from the Center for Rehabilitation Medicine at Emory University in Atlanta, Georgia. Enrollment of participants began in June 2010 and study participation ended in April 2012.
Pre-assignment Details A total of 124 patients were screened and of these 14 met enrollment criteria and consented to participate in the study.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Period Title: Overall Study
Started 7 7
Completed 7 6
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy Participants taking a placebo pill and using the HandMentor Pro for robotic therapy Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
Only participants that completed the study are included in the baseline analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
57.7  (7.3) 53.7  (18.4) 55.8  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
7
 100.0%
3
  50.0%
10
  76.9%
Male
0
   0.0%
3
  50.0%
3
  23.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  85.7%
4
  66.7%
10
  76.9%
White
1
  14.3%
2
  33.3%
3
  23.1%
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 7 participants 6 participants 13 participants
7
 100.0%
6
 100.0%
13
 100.0%
1.Primary Outcome
Title Grip Strength of Affected Hand
Hide Description Hand-grip strength was assessed using the whole hand and was defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. An increase in values means that grip strength is improving.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the study are included in this analysis.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: Newton
Baseline 3.95  (2.96) 5.72  (3.98)
Day 30 4.90  (3.56) 8.44  (4.90)
2.Secondary Outcome
Title Percentage of Stroke Impact Scale (SIS) Categories Meeting Change Criteria
Hide Description The percentages of Stroke Impact Scale (SIS) physical domain categories meeting criteria for Minimal Clinically Important Difference (MCID) are presented here. The SIS has 59 items in 8 domains of function where respondents rate their degree of difficulty on a 5-point scale, plus a 9th category for stroke recovery (one item, scored from 0 to 100). Scores for each domain are generated so that total scores for each domain range from 0 - 100, where higher scores indicate less difficulty and more recovery. A change of more than 4.5 to 17.8 for the domains was considered a MCID. A higher percentage of SIS categories meeting the MCID criteria indicates increased improvement in that study arm.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the study are included in this analysis.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: percentage of category scores
44.4 24.1
3.Secondary Outcome
Title Center for Epidemiologic Studies Depression (CES-D) Scale Score
Hide Description Depressive symptoms were assessed with the Center for Epidemiologic Studies Depression (CES-D) Scale. The CES-S has 20 items rated on a scale of 0 to 3. Total scores range from 0 to 60 with higher scores indicating more depressive symptoms, and a score of 16 or above indicates depression. Baseline scores are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the study are included in this analysis.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.1  (6.5) 9.2  (8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments Values represent the time x treatment group interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.651
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter F statistic
Estimated Value 0.216
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Display Enhanced Testing for Concussions and Mild Traumatic Brain Injury (mTBI) (DETECT) System Score
Hide Description Using a computer, helmet with heads-up-display, headphones with audio inputs, and an input unit with two buttons (“Yes” and “No”), the DETECT system combines an immersive environment with neuropsychological tests to assess mTBI. The DETECT software consists of a series of tests evaluating information processing speed, episodic memory, and working memory. Performance is scored based on response type (correct, incorrect, and missing) and response time. Test results are displayed using an internal algorithm that is based on the probability of impairment. Mean baseline z-scores are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section. A z-score of 0 represents a healthy individual; scores above 0 are the number of standard deviations above the mean, indicating more errors, taking more time, and thus having a higher probability of mild cognitive impairment.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with complete information for the DETECT measurement are included in this analysis. Two participants had missing values dues to technical issues with the instrument.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: z-score
10.2  (0.0) 10.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments Values represent the time x treatment group interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter F statistic
Estimated Value 0.633
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Blocks Moved During the Box and Block Test (BBT) of Affected Arm
Hide Description Change in functional motor task performance of the arm affected by the stroke was assessed with the Box and Block Test (BBT). The BBT involves dexterous manipulation of objects and voluntary motor control, which improves with upper limb recovery following stroke. The number of blocks moved within 60 seconds are counted. Baseline scores of the mean number of blocks moved are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the study are included in this analysis.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: blocks per minute
9.7  (7.9) 9.6  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments Values represent the time x treatment group interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter F statistic
Estimated Value 0.557
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from the time each participant consented to take part in the trial through the end of study follow up (30 days). Adverse events for all participants who began the study are presented, regardless of whether or not they finished the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Andrew John Butler
Organization: Emory University
Phone: 404-413-1415
Responsible Party: Andrew Butler, PhD, Emory University
ClinicalTrials.gov Identifier: NCT02082912     History of Changes
Other Study ID Numbers: IRB00035176
UL1TR000454 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2014
First Posted: March 10, 2014
Results First Submitted: April 9, 2015
Results First Posted: April 22, 2015
Last Update Posted: November 7, 2018