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Non-invasive Brain Stimulation

tDCS + CCFES for Stroke-related Hand Weakness

N/A

Recruiting

Led By David A Cunningham, PhD

Research Sponsored by MetroHealth Medical Center

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 in the workspace for table-top task practice

Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale

Must not have

Insensate arm, forearm, or hand

Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Summary

This trial will compare 3 non-invasive brain stimulation protocols to see which best helps stroke survivors regain hand movement through OT and PT.

Who is the study for?

This trial is for adults aged 21-90 who've had a stroke within the last 6-24 months, resulting in upper limb weakness but can still open their hand somewhat. They must be able to follow commands, remember things short-term, and sit unassisted. Excluded are those with seizure disorders, other neurological conditions, implanted electronic devices, pregnancy, recent Botox injections in the arm muscles or severe cognitive impairments.

What is being tested?

The study tests three types of non-invasive brain stimulation combined with occupational therapy to improve hand movement after a stroke. Participants will receive either conventional tDCS (transcranial direct current stimulation), unconventional tDCS montages plus CCFES (Contralaterally Controlled Functional Electrical Stimulation), or sham tDCS plus CCFES.

What are the potential side effects?

tDCS may cause mild side effects like itching or tingling at the electrode site on the scalp during application; headache; fatigue; nausea; and difficulty concentrating post-treatment. These are typically temporary and resolve soon after treatment.

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 use my hand for table tasks.

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I have weakness in one arm, making it hard to fully extend my fingers.

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My skin is unbroken on my weaker side's arm, hand, and head.

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I am between 21 and 90 years old.

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I can fully move and use my unaffected arm and hand.

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I can sit by myself in a chair without arms for the screening.

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I can extend my fingers and wrist by at least 10 degrees.

Exclusion Criteria

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

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I cannot feel my arm, forearm, or hand.

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I cannot move my hand or shoulder without severe pain.

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I have severe difficulties in thinking and communicating.

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I have seizures that are not controlled by medication.

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I have communication issues that may affect my participation in the study.

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I have not had Botox injections in my arm muscles in the last 3 months.

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I have a neurological condition besides a stroke that affected my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in uefm will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in uefm will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in uefm will be assessed at 6 weeks, 12 weeks, 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

Box and Blocks Test (BBT)

Secondary study objectives

Upper Extremity Fugl-Meyer Assessment (UEFM).

Other study objectives

Neurophysiologic Assessments

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active conventional tDCS plus CCFESActive Control2 Interventions

The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group II: Active unconventional tDCS plus CCFESActive Control2 Interventions

The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group III: Sham tDCS plus CCFESPlacebo Group2 Interventions

The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.

0 / 14Eligibility criteria met