Trial Outcomes & Findings for Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury (NCT NCT00387673)
NCT ID: NCT00387673
Last Updated: 2017-06-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing
Results posted on
2017-06-16
Participant Flow
Participant milestones
| Measure |
Arm 1
6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
|
Arm 2
a 6-week period of 2 hours somatosensory stimulation of the hand, without training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
|
Arm 3
a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
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Overall Study
STARTED
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0
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0
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0
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Overall Study
COMPLETED
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0
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Effect of Prolonged Electrical Stimulation on Neural Plastici
|
|---|---|
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Sex: Female, Male
Female
|
0
n=5 Participants
|
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Sex: Female, Male
Male
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0
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testingPopulation: Project has officially closed. PI for this project has left VA without forwarding information.
Outcome measures
Outcome data not reported
Adverse Events
Project Closed
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place