N/A
N=22
Combined Neural and Behavioral Therapies to Enhance Stroke Recovery
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00929656 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Wolf Motor Function Test Change — 1.6; 1.8 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real rTMS (Procedure); Sham rTMS (Procedure); Unimanual paretic UE Training (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test Change |
1.6; 1.8 | — |
| SECONDARY Upper Extremity Fugl-Meyer Motor Assessment Change |
5.8; 5.8 | — |
| SECONDARY Grip Strength Change |
1.1; 1.3 | — |
| SECONDARY Motor Activity Log - Amount of Use Change |
1.3; 1.2 | — |
| SECONDARY Motor Activity Log - How Well Change |
1.1; 1.2 | — |
Summary
Stroke is the leading cause of long-term disability in this country with more than 1 million Americans reporting difficulty with daily activities. Loss of independence in self-care tasks is primarily due to limited recovery of the arm. This study will determine if the addition of Transcranial Magnetic Stimulation (TMS) to excite the lesioned hemisphere (side of the brain affected by the stroke), to progressive functional task exercise either of the weakened arm alone or of both arms together will improve arm recovery to a greater degree than one of these two types of arm exercise alone. Individuals post-stroke will participate in 16 sessions of 1) arm rehabilitation alone (with the weaker arm only or with both arms together) or 2) arm rehabilitation plus TMS. The investigators will assess arm movement ability and function immediately following the 4-week intervention and at a 30-day follow-up to determine retention of immediate gains. The investigators hypothesize that those who receive TMS as an adjuvant will have improved arm movement ability than those who only exercise.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of 1st stroke > 6 months
- Sub-cortical stroke confirmed with CT or MRI
- Passive range of motion in bilateral shoulder and elbow within functional limits
- UE Fugl-Meyer shoulder/elbow subcomponent score between 15 - 25
- 18-80 years of age
Exclusion Criteria
- Use of medications that may lower seizure threshold
- History of epilepsy, brain tumor, learning disorder, mental retardation, drug or alcohol abuse, dementia, major head trauma, or major psychiatric illness
- evidence of epileptiform activity on EEG obtained before beginning treatment
- history or radiographic evidence of arteriovenous malformation, intracortical hemorrhage, subarachnoid hemorrhage, or bilateral cerebrovascular disease,
- history of cortical stroke
- history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull
- pregnancy
- pain in either upper extremity that would interfere with movement
- unable to understand 3-step directions
- orthopedic condition in back or UE or impaired corrected vision that would alter kinematics of reaching
Data sourced from ClinicalTrials.gov (NCT00929656). 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.