NCT03870672Active, not recruiting
rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
Contralaterally Controlled FES Combined With Brain Stimulation for Severe Upper Limb Hemiplegia
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 6 Mar 2019
- Start date
- 14 May 2019
- Primary completion date
- 23 Jul 2026
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Stroke
- NCT number
- NCT03870672
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 14 May 2019 to the primary completion date, 23 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- metal implant in the head
- history of alcohol or substance abuse less than 10yrs prior to enrollment
Other illness
- history of seizures as an adult
- cardiac pacemaker or other programmable implant
Other
- intake of anticonvulsants or anti-depressants contraindicated with TMS
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lerner Research Institute; Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.