Trial Outcomes & Findings for Spinal Plasticity to Enhance Motor Retraining After Stroke (NCT NCT03645122)
NCT ID: NCT03645122
Last Updated: 2024-09-19
Results Overview
A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Measured under each condition, with approximately 2 months required for completion of all conditions.
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
PCMS Rest, Sham, PCMS Active
Participants completed 3 conditions in the following randomized order: PCMS Rest, Sham, PCMS Active
|
Sham, PCMS Rest, PCMS Active
Participants completed 3 conditions in the following randomized order: Sham, PCMS Rest, PCMS Active
|
PCMS Active, Sham, PCMS Rest
Participants completed 3 conditions in the following randomized order: PCMS Active, Sham, PCMS Rest.
|
Sham, PCMS Active, PCMS Rest
Participants completed 3 conditions in the following randomized order: Sham, PCMS Active, PCMS Rest
|
PCMS Rest, PCMS Active, Sham
Participants completed 3 conditions in the following randomized order: PCMS Rest, PCMS Active, Sham.
|
PCMS Active, PCMS Rest, Sham
Participants completed 3 conditions in the following randomized order: PCMS Active, PCMS Rest, Sham.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
5
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Plasticity to Enhance Motor Retraining After Stroke
Baseline characteristics by cohort
| Measure |
Condition
n=23 Participants
1. Rest PCMS: PCMS was administered with the targeted hand muscles at rest.
2. Sham: Peripheral nerve stimulation was administered and the stimulating coil discharged when subjects achieved a criterion level of force stability during task repetition. The stimulating coil was rotated to prevent activation of the brain, thus, preventing PCMS.
3. Active PCMS: PCMS was administered when subjects achieved a criterion level of force stability during task repetition.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured under each condition, with approximately 2 months required for completion of all conditions.A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.
Outcome measures
| Measure |
Rest PCMS
n=23 Participants
PCMS administered with the targeted hand muscles at rest.
|
Sham PCMS
n=23 Participants
Peripheral nerve stimulation administered and the stimulating coil discharged when subjects achieved a criterion level of force stability during task repetition. Stimulating coil rotated to prevent activation of the brain, thus, preventing PCMS.
|
Active PCMS
n=23 Participants
PCMS administered when subjects achieved a criterion level of force stability during task repetition.
|
|---|---|---|---|
|
Motor Control & Learning
|
0.339 Newton
Standard Error 0.141
|
0.359 Newton
Standard Error 0.139
|
0.301 Newton
Standard Error 0.115
|
Adverse Events
Rest PCMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham PCMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active PCMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Director for Clinical and Regulatory Affairs
VA Pittsburgh Healthcare System
Phone: 412-822-3669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place