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rTMS and CCFES for Severe Stroke Recovery

This study is testing new ways to help people recover arm and hand movement after a severe stroke. It combines a treatment called repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses to stimulate the brain, with Contralaterally Controlled Functional Electrical Stimulation (CCFES). CCFES uses electrical stimulation to help open a weak hand. You might be able to join if you are 18-90 years old, had a stroke more than 6 months ago, and have severe weakness in your arm and hand. The study will look at how much your arm and hand function improves over 36 weeks. The current status of this study is unclear.

Study design
This is a randomized controlled trial with 72 participants. It compares three different approaches: CCFES with a new rTMS approach, CCFES with a conventional rTMS approach, and CCFES with a sham (inactive) rTMS approach.
What's involved
You would receive 10 sessions per week of self-administered CCFES-assisted hand opening exercises at home, plus 2 sessions per week of rTMS and CCFES-mediated functional task practice in the laboratory, for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your arm and hand function will be assessed at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03870672

rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke

Active, Not Recruiting
NAAges 18–90InterventionalTreatment
The Cleveland Clinic
~72 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Contralaterally Controlled Functional Electrical StimulationNew rTMS approachConventional rTMS approachSham rTMS approach

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Upper Extremity Fugl-Meyer (UEFM)
Measured over Change in UEFM will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks.

Conditions

Stroke
Hemiplegia
Cerebrovascular Accident (CVA)
Hemiparesis

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NCT03870672

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Lerner Research Institute; Cleveland Clinic Foundation

    Cleveland, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ela B Plow, PhD PT · PRINCIPAL_INVESTIGATOR · Lerner Research Institute; Cleveland Clinic Foundation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Upper Extremity Fugl-Meyer (UEFM)Change in UEFM will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks.

    The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment. The UEFM items take into account synergy patterns, isolated strength, coordination, and hypertonia. Volitional movement of the upper limb (shoulder, elbow, forearm, wrist, and hand) is examined in and out of synergies. Each item is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a maximum score of 66. The UEFM is classified as a body structure/function impairment measure on the ICF domain.