Combining brain stimulation with rehabilitation for severe stroke recovery
Contralaterally Controlled FES Combined With Brain Stimulation for Severe Upper Limb Hemiplegia
This study is testing a new therapy that combines brain stimulation with rehabilitation exercises to see if it can help people with severe stroke recover better use of their arms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03870672 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new therapy aimed at improving upper limb function in patients with severe motor impairment following a stroke. It employs repetitive transcranial magnetic stimulation (rTMS) to stimulate the undamaged hemisphere of the brain, combined with contralaterally controlled functional electrical stimulation (CCFES) to enhance rehabilitation outcomes. Over a period of 12 weeks, participants will engage in both home-based exercises and laboratory sessions to assess the effectiveness of this combined approach. The study will evaluate functional abilities and neurophysiological changes at multiple time points to determine the long-term benefits of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who are more than 6 months post-stroke with severe upper limb hemiparesis.
Not a fit: Patients with minimal active movement in their upper limbs or those who have not completed prior occupational therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve upper limb function and quality of life for patients with severe stroke-related impairments.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific combination of rTMS and CCFES is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18 to 90 years old at time of randomization * greater than 6 months since a first clinical cortical or subcortical, ischemic or hemorrhagic stroke * severe upper limb hemiparesis defined as less than 10° active wrist extension or less than 10° active thumb abduction/extension or less than 10° active extension in at least two additional digits (i.e., will not meet minimum CIMT criteria) * ability to follow 3-stage commands and can remember 2 items from a list of 3 items after 3 minutes * adequate active movement of shoulder and elbow to position the paretic hand on one's lap for performance of functional task practice and CCFES-assisted hand opening exercises * skin intact on hemiparetic arm * surface electrical stimulation of the paretic finger and thumb extensors produces functional hand opening without pain * able to hear and respond to cues from stimulator * completed occupational therapy at least 2 months prior to enrollment (no concomitant OT) * full volitional hand opening/closing of the non-paretic hand * ability to follow instructions for putting on and operating the CCFES stimulator or a caregiver available to provide assistance Exclusion Criteria: * metal implant in the head * history of seizures as an adult * history of alcohol or substance abuse less than 10yrs prior to enrollment * intake of anticonvulsants or anti-depressants contraindicated with TMS * cardiac pacemaker or other programmable implant
Where this trial is running
Cleveland, Ohio
- Lerner Research Institute; Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ela B Plow, PhD PT — Lerner Research Institute; Cleveland Clinic Foundation
- Study coordinator: Kyle J. O'Laughlin, MS
- Email: olaughk@ccf.org
- Phone: 866-449-1394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.