Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Northwell Health
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Median Change in Upper Extremity Fugl Meyer Assessment Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
Investigators
Bruce Volpe
Principal Investigator
Northwell Health
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- •Cognitive function sufficient enough to understand experiments and follow instructions
- •Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria
- •Botox treatment within 6 weeks of enrollment
- •Fixed contraction of the affected limb
- •Complete flaccid paralysis of the affected limb
- •History of hemorrhagic stroke
- •Ongoing use of CNS active medications
- •Ongoing use of psychoactive medications
- •Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
Outcomes
Primary Outcomes
Median Change in Upper Extremity Fugl Meyer Assessment Score
Time Frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Secondary Outcomes
- Median Change in WOLF Motor Function Test (WMFT)(baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention))
- Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)(12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention))