What is the mechanism of action of this treatment?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that excites specific motor cortices, such as the contralesional higher motor cortices (cHMC), to enhance motor recovery in Hemiplegia patients. By stimulating these areas, rTMS promotes neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for Hemiplegia patients as it can lead to improved motor function and recovery of movement in the affected limbs. Combining rTMS with rehabilitation therapies like contralaterally controlled functional electrical stimulation (CCFES) can produce synergistic effects, further enhancing functional abilities and aiding in long-term recovery.

What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive treatment used to enhance motor recovery in hemiplegia by exciting specific motor cortices. Known side effects of rTMS include mild and transient events such as headaches, scalp discomfort at the stimulation site, and muscle twitches. Serious adverse events are rare but can include seizures, particularly in patients with a predisposition to epilepsy. Other treatments for hemiplegia, such as functional electrical stimulation (FES), may cause skin irritation, muscle soreness, and discomfort at the electrode sites.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for hemiplegia that directly align with the mechanism of action of repetitive transcranial magnetic stimulation (rTMS). However, rTMS itself has shown promise in clinical trials for enhancing motor recovery in stroke patients, which is a common cause of hemiplegia. Other treatments for motor recovery post-stroke include physical therapy, occupational therapy, and certain medications like botulinum toxin for spasticity management, but these do not function in the same way as rTMS.

What other types of research exist?

Promising novel alternatives to rTMS for hemiplegia patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving motor function by modulating cortical excitability. 2) Constraint-Induced Movement Therapy (CIMT), which encourages the use of the affected limb by restricting the unaffected limb. 3) Epidural Cortical Stimulation, which has been explored as an adjunctive treatment for enhancing motor recovery. 4) Combining pharmacological agents like memantine or donepezil with intensive rehabilitation therapies to enhance neuroplasticity and functional recovery.

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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)

Must not have

Intake of anticonvulsants or anti-depressants contraindicated with TMS

History of seizures as an adult

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.

Summary

This trial tests a new therapy for stroke patients with severe arm and hand movement issues. It combines brain stimulation with muscle electrical stimulation to improve recovery. The goal is to see if this combination works better than other treatments.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking any medications that interfere with TMS.

Select...

I have had seizures as an adult.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Upper Extremity Fugl-Meyer (UEFM)

Other study objectives

Change in Neurophysiologic Assessments

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 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that excites specific motor cortices, such as the contralesional higher motor cortices (cHMC), to enhance motor recovery in Hemiplegia patients. By stimulating these areas, rTMS promotes neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for Hemiplegia patients as it can lead to improved motor function and recovery of movement in the affected limbs. Combining rTMS with rehabilitation therapies like contralaterally controlled functional electrical stimulation (CCFES) can produce synergistic effects, further enhancing functional abilities and aiding in long-term recovery.