rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke (NCT03870672)
Contralaterally Controlled FES Combined With Brain Stimulation for Severe Upper Limb Hemiplegia
🩺 Plain-English Summary (8th-Grade Level)
This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment. It is the first clinical trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive results obtained in our short-term pilot study can be made to last longer and produce functional benefits in severe patients with the application of brain stimulation in combination with long-term rehabilitation therapy. Rehabilitation therapy administered is called contralaterally controlled functional electrical stimulation (CCFES). Determining whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in functional abilities in severe patients is necessary for acceptance by the clinical community and to move this technology toward commercialization and widespread dissemination. The proposed study will determine whether the combination of rTMS facilitating the cHMC with CCFES produces greater improvements in upper extremity function in severe participants who are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the combination of sham rTMS and CCFES. The secondary purposes are to define which patients benefit most from the treatments, which may inform future device and treatment development and clinical translation, and to explore what distinct effects the three treatments have on the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls severe stroke patients.
Who can join: Review the eligibility criteria below.
Location: Lerner Research Institute; Cleveland Clinic Foundation — Cleveland, Ohio
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Lerner Research Institute; Cleveland Clinic Foundation — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (866) 223-8100
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stroke
- Validation of a Spasticity Measurement Tool — Chicago, Illinois
- GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors. — Boston, Massachusetts
- Determining the Optimal Dose of Reactive Balance Training After Stroke — Toronto, Ontario
- AMPLATZER PFO Occluder Post Approval Study — Birmingham, Alabama
- Reflex Excitability in Post-stroke Stiff-Knee Gait — Cleveland, Ohio
- Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA) — Dallas, Texas
Explore by condition: All Stroke clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.