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NCT03870672 · ClinicalTrials.gov registry record · NA
rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
A NA study of Stroke and Hemiparesis, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT03870672 is a NA study of Stroke and Hemiparesis that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 72 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03870672, a NA study of Stroke and Hemiparesis, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Contralaterally Controlled Functional Electrical Stimulation
- DEVICE New rTMS approach
- DEVICE Conventional rTMS approach
- DEVICE Sham rTMS approach
Study Locations (1)
Ohio
- Lerner Research Institute; Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03870672
The ClinicalTrials.gov registry entry for NCT03870672 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stroke appearing as the primary indexed condition, and to 4 interventions - of which Contralaterally Controlled Functional Electrical Stimulation is the first listed.
NCT03870672 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03870672 about?
NCT03870672 is a clinical study titled "rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke". 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 th...
What is the current status of trial NCT03870672?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2019-05-14. Estimated completion is 2026-04-30.
What conditions does trial NCT03870672 study?
This clinical trial studies the following conditions: Stroke, Hemiparesis, Hemiplegia, Cerebrovascular Accident (CVA).
What interventions are being tested in trial NCT03870672?
The interventions under investigation include: Contralaterally Controlled Functional Electrical Stimulation (DEVICE), New rTMS approach (DEVICE), Conventional rTMS approach (DEVICE), Sham rTMS approach (DEVICE).
Who is sponsoring clinical trial NCT03870672?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03870672 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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