NCT03870672 rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
| NCT ID | NCT03870672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2019-05-14 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2019-05-14 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Ela B Plow, PhD PT
PRINCIPAL INVESTIGATOR
Lerner Research Institute; Cleveland Clinic Foundation
Frequently Asked Questions
Who can join the NCT03870672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03870672 currently recruiting?
Yes, NCT03870672 is actively recruiting participants. Contact the research team at olaughk@ccf.org for enrollment information.
Where is the NCT03870672 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03870672 clinical trial?
NCT03870672 is sponsored by The Cleveland Clinic. The principal investigator is Ela B Plow, PhD PT at Lerner Research Institute; Cleveland Clinic Foundation. The trial plans to enroll 72 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.