Phase 2
N=21
Driving Neuroplasticity With Nerve Stimulation and Modified CIT
Stroke · Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT02587234 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Wolf Motor Function Test (WMFT), Timed Portion — -0.36; -0.18; -0.37; -0.15 log(seconds)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- peripheral nerve stimulation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Kentucky
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wolf Motor Function Test (WMFT), Timed Portion |
-0.36; -0.18; -0.37; -0.15 | — |
| SECONDARY Change in Fugl Meyer Assessment Motor Score |
10.2; 5.6; 12.5; 6.3 | — |
| SECONDARY Change in Action Research Arm Test (ARAT) |
9.6; 3.67; 11.1; 4.43 | — |
Summary
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).
Eligibility Criteria
Inclusion Criteria
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion Criteria
- History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
- History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Participants with history of untreated depression.
Data sourced from ClinicalTrials.gov (NCT02587234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.