A Novel Approach for Brain Stimulation in Severe Stroke
Completed · Early Phase 1
Conditions studied: Stroke
In brief
The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 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 * 12 intervention visits during which patients will receive upper limb training in conjunction 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
Key facts
- Study ID
- NCT03868410
- Run by
- The Cleveland Clinic
- People needed
- 16
- Starts
- 2019-04-01
- Expected to finish
- 2023-07-13
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- chronic phase (≥6 months) after index stroke
- moderate or severely impaired (UEFM ≤42)
- have either extensive damage to ipsilesional pathways (MEP-), or, have one of the following: less than 10 degrees active wrist extension, less than 10 degrees active thumb extension/abduction, less than 10 degrees active extension in at least 2 additional digits (i.e. will not meet minimum Constraint-Induced Movement Therapy [CIMT] criteria).
- medically stable
You may not qualify if…
- cerebellar stroke
- brainstem stroke
- bilateral strokes affecting sensorimotor structures
- severe cognitive impairment
- substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale >3)
- severe contracture
- participation in outpatient or Botox therapy within 2 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).
Where it is running
- Lerner Research Institute; Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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