The long-term goal of this clinical trial is to develop upper limb rehabilitation interventions that stroke survivors can use. It is specifically being conducted for survivors with more severe limitations of their affected upper limb.
This study will use a method of non-invasive brain stimulation combined with upper limb training given for 15 visits over a period of 5 weeks.
The study will include the following site visits:
- Eligibility Screening and Informed Consent Visit
- An MRI visit
- Two testing visits in which motor function of the upper limb and neurophysiology will be measured
- Fifteen intervention visits during which patients will receive upper limb training combined with non-invasive brain stimulation
- Repeat testing of motor function of the upper limb and neurophysiology
- Repeat MRI testing
- A follow-up visit completed 3 months after the completion of interventions
This is an interventional, quadruple-blind, randomized, parallel assignment for the primary purpose of treatment after a severe stroke. There is an estimated 24 participants. The study began on April 1, 2019 and is expected to be completed by September 30, 2021.
- Chronic phase (≥6 months) after index stroke
- Moderate or severely impaired (UEFM ≤42) with extensive damage to ipsilesional pathways (MEP-)
- Able to perform the reaching-response time task
- Medically stable
- Cortical stroke affecting motor areas (identified using T1-weighted MRI)
- Brainstem stroke
- Bilateral strokes
- Severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≤ 24)
- Substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale >3)
- Severe contracture
- Participation in outpatient or Botox therapy within 3 months
- Exclusion criteria for TMS and MRI (metal implant in head, H/O seizures, alcohol or substance abuse, intake of medications contraindicated with TMS, cardiac pacemaker or programmable implant)
You may participate in this study at the Lerner Research Institute; Cleveland Clinic Foundation in Cleveland, Ohio, United States, 44195. If you have any questions or concerns you may contact Morgan Widina, MS at 866-449-1394 or at firstname.lastname@example.org.
This study is sponsored by The Cleveland Clinic and collaborated by the American Heart Association. Ela Plow, PhD of the Lerner Research Institute; Cleveland Clinic Foundation serves as the Principal Investigator.
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