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Behavioural Intervention

rTMS + CCFES Therapy for Severe Stroke (rTMS+CCFES Trial)

N/A

Recruiting

Led By Ela B Plow, PhD PT

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in uefm will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks.

Awards & highlights

rTMS+CCFES Trial Summary

This trial is testing whether a new therapy consisting of non-invasive brain stimulation and long-term rehabilitation therapy can help improve upper limb function in severe stroke patients.

Who is the study for?

This trial is for adults aged 18-90 who had a severe stroke at least 6 months ago, resulting in significant upper limb weakness. They must be able to follow commands and have no recent history of seizures or substance abuse. People with metal head implants, pacemakers, or those on certain medications cannot join.Check my eligibility

What is being tested?

The study tests if a new rTMS approach targeting the undamaged brain hemisphere combined with CCFES therapy improves arm function in severe stroke patients more than conventional rTMS or sham treatments.See study design

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures (very rare). CCFES might lead to skin irritation under the electrodes and muscle fatigue from electrical stimulation.

rTMS+CCFES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my shoulder and elbow enough to place my hand on my lap for exercises.

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I have severe weakness in my arm, unable to move my wrist or fingers properly.

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Electrical stimulation helps open my hand without causing pain.

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I can follow complex instructions and remember things well.

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I am between 18 and 90 years old.

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The skin on my weaker arm is not broken or damaged.

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I can fully open and close my non-affected hand.

rTMS+CCFES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in uefm will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in uefm will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in uefm will be assessed at at 6 weeks, 12 weeks (end of treatment), 24 weeks, and 36 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Upper Extremity Fugl-Meyer (UEFM)

Other outcome measures

Change in Neurophysiologic Assessments

rTMS+CCFES Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: CCFES + rTMS facilitating iM1Active Control2 Interventions

This rTMS paradigm is the "Conventional Approach".Facilitation of M1 will be achieved using 5Hz rTMS. After rTMS, the participant will participate in one hour of CCFES-mediated functional task practice. The therapist will instruct and guide the participants in practicing functional tasks with their paretic hand with the assistance of CCFES. Tasks will involve using the paretic hand to pick up, manipulate, and release objects commonly used in daily life. Early sessions will focus on simpler tasks, such as practicing opening the hand adequately to acquire an object.

Group II: CCFES + rTMS facilitating cHMCActive Control2 Interventions

This rTMS paradigm is the "New Approach". Facilitation of the intact hemisphere target (cHMC) will be achieved using 5Hz rTMS. After rTMS, the participant will participate in one hour of CCFES-mediated functional task practice. The therapist will instruct and guide the participants in practicing functional tasks with their paretic hand with the assistance of CCFES. Tasks will involve using the paretic hand to pick up, manipulate, and release objects commonly used in daily life. Early sessions will focus on simpler tasks, such as practicing opening the hand adequately to acquire an object.

Group III: CCFES + Sham rTMSPlacebo Group2 Interventions

This rTMS paradigm is the "Sham Approach". Immediately after sham rTMS, the participant will participate in one hour of CCFES-mediated functional task practice. The therapist will instruct and guide the participants in practicing functional tasks with their paretic hand with the assistance of CCFES. Tasks will involve using the paretic hand to pick up, manipulate, and release objects commonly used in daily life. Early sessions will focus on simpler tasks, such as practicing opening the hand adequately to acquire an object.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,486 Total Patients Enrolled

1 Trials studying Hemiplegia

132 Patients Enrolled for Hemiplegia

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,725 Total Patients Enrolled

7 Trials studying Hemiplegia

440 Patients Enrolled for Hemiplegia

Ela B Plow, PhD PTPrincipal InvestigatorLerner Research Institute; Cleveland Clinic Foundation

2 Previous Clinical Trials

87 Total Patients Enrolled

Media Library

Contralaterally Controlled Functional Electrical Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03870672 — N/A

Hemiplegia Research Study Groups: CCFES + rTMS facilitating iM1, CCFES + rTMS facilitating cHMC, CCFES + Sham rTMS

Hemiplegia Clinical Trial 2023: Contralaterally Controlled Functional Electrical Stimulation Highlights & Side Effects. Trial Name: NCT03870672 — N/A

Contralaterally Controlled Functional Electrical Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03870672 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research encompass those aged 50 and above?

"Admittance to this trial is open to those who are of legal age and below the age of 90."

Answered by AI

Is it possible to partake in the current clinical experiment?

"This clinical trial seeks to enrol 72 participants ranging between 18 and 90 years of age, who have had a stroke. Furthermore, the following criteria must be satisfied for inclusion: adequate movement in the shoulder and elbow region allowing one to position their affected hand on their lap; skin integrity on the hemiparetic arm; capacity to understand 3-stage commands as well as recall 2 items from a list after 3 minutes; severe impairment in upper limb mobility (failure to meet CIMT qualifications); 6 or more months since suffering an ischemic/hemorrhagic stroke; hearing intactness coupled with ability to respond appropriately when stimulated during"

Answered by AI

Is this medical trial currently enrolling participants?

"Affirmative. Current information hosted on clinicaltrials.gov states that this experiment is presently enrolling participants and was initially posted on May 14th 2019. Subsequently, it has been edited as recently as March 8th 2022 with the aim of selecting 72 patients from a single centre."

Answered by AI

How many participants have registered for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this research trial is actively recruiting participants who wish to contribute data and help advance medical science. The study was first posted on May 14th 2019 before being updated for the last time March 8th 2022; 72 volunteers are necessary between 1 location."

Answered by AI

Recent research and studies

Frontiers in NeurologyJournal

Contralaterally Controlled Functional Electrical Stimulation Combined with Brain Stimulation for Severe Upper Limb Hemiplegia—study Protocol for a Randomized Controlled Trial

Mohan, Akhil, Jayme S. Knutson, David A. Cunningham, Morgan Widina, Kyle O'Laughlin, Tarun Arora, Xin Li, et al.. 2022. “Contralaterally Controlled Functional Electrical Stimulation Combined with Brain Stimulation for Severe Upper Limb Hemiplegia—study Protocol for a Randomized Controlled Trial”. Frontiers in Neurology. Frontiers Media SA. doi:10.3389/fneur.2022.869733.

clinicaltrials.govStudy

rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke

Ela B. Plow 2019. "rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03870672.

All > Hemiplegia > Stroke