Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Median Change in Upper Extremity Fugl Meyer Assessment Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
tDCS + robotic arm therapy
Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Intervention: Transcranial Direct Current Stimulation (tDCS) (Device)
tDCS sham + robotic arm therapy
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Intervention: Placebo sham (Device)
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))
Investigators
Bruce Volpe
Principal Investigator
Northwell Health