Trial Outcomes & Findings for NMDA Receptors in Motor Learning in Humans (NCT NCT02082912)
NCT ID: NCT02082912
Last Updated: 2018-11-07
Results Overview
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.
COMPLETED
PHASE2
14 participants
Baseline, Day 30
2018-11-07
Participant Flow
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.
A total of 124 patients were screened and of these 14 met enrollment criteria and consented to participate in the study.
Participant milestones
| Measure |
D-cycloserine
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
D-cycloserine
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
NMDA Receptors in Motor Learning in Humans
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=7 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=6 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 18.4 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30Population: Participants completing the study are included in this analysis.
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.
Outcome measures
| Measure |
D-cycloserine
n=7 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=6 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Grip Strength of Affected Hand
Baseline
|
3.95 Newton
Standard Deviation 2.96
|
5.72 Newton
Standard Deviation 3.98
|
|
Grip Strength of Affected Hand
Day 30
|
4.90 Newton
Standard Deviation 3.56
|
8.44 Newton
Standard Deviation 4.90
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Participants completing the study are included in this analysis.
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.
Outcome measures
| Measure |
D-cycloserine
n=7 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=6 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Percentage of Stroke Impact Scale (SIS) Categories Meeting Change Criteria
|
44.4 percentage of category scores
|
24.1 percentage of category scores
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Participants completing the study are included in this analysis.
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.
Outcome measures
| Measure |
D-cycloserine
n=7 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=6 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Center for Epidemiologic Studies Depression (CES-D) Scale Score
|
15.1 units on a scale
Standard Deviation 6.5
|
9.2 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: 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.
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.
Outcome measures
| Measure |
D-cycloserine
n=6 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=5 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Display Enhanced Testing for Concussions and Mild Traumatic Brain Injury (mTBI) (DETECT) System Score
|
10.2 z-score
Standard Deviation 0.0
|
10.1 z-score
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Participants completing the study are included in this analysis.
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.
Outcome measures
| Measure |
D-cycloserine
n=7 Participants
Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
|
Placebo
n=6 Participants
Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
|
|---|---|---|
|
Number of Blocks Moved During the Box and Block Test (BBT) of Affected Arm
|
9.7 blocks per minute
Standard Deviation 7.9
|
9.6 blocks per minute
Standard Deviation 6.2
|
Adverse Events
D-cycloserine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place