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Electrical Stimulation

Brain & Muscle Stimulation for Stroke Rehabilitation

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

Full volitional elbow extension/flexion and hand opening/closing of unaffected limb

Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes

Must not have

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

Uncontrolled seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one hour post intervention

Awards & highlights

Summary

This trialwill study how electrical brain and muscle stimulation may improve hand movement in stroke patients with paralysis.

Who is the study for?

This trial is for stroke survivors over 21 years old with chronic upper limb hemiplegia, who can follow commands and have some finger movement. They must be medically stable, able to sit unassisted, and at least 6 months post-stroke. Excluded are pregnant individuals, those with other neurological conditions or severe pain in the affected limb, recent botox injections in the arm muscles, certain metal implants or electronic devices.

What is being tested?

The study tests how non-invasive brain stimulation (tDCS) combined with functional electrical stimulation affects hand motor control in stroke patients. It explores optimal timing and delivery methods of these treatments to improve hand function.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp or skin irritation from electrodes used during electrical stimulation. There's also a small risk of seizure due to brain stimulation but precautions are taken to minimize this.

Eligibility Criteria

Inclusion Criteria

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

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

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I can follow complex instructions and remember things well.

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I do not have major issues with my sight or hearing.

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

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

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I can move my shoulder and elbow enough to use my hand for table-top tasks.

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I can extend my fingers at least 10 degrees.

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I am 21 years old or older.

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I have weakness in one arm and some hand movement ability.

Exclusion Criteria

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

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I cannot move my hand or shoulder without severe pain.

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I have seizures that are not controlled by medication.

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I have a neurological condition besides a past stroke affecting my arm.

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I have severe difficulties in thinking and communicating.

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

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I cannot feel my arm, forearm, or hand.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one hour post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one hour post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one hour post intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Corticospinal Excitability

Reaction Time

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: unconventional tDCS preceding CCFESExperimental Treatment1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group II: unconventional tDCS concurrent with CCFESExperimental Treatment1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group III: conventional tDCS preceding CCFESExperimental Treatment1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group IV: conventional tDCS concurrent with CCFESExperimental Treatment1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group V: sham tDCS with CCFESPlacebo Group1 Intervention

sham tDCS preceding and concurrent with CCFES

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor

115 Previous Clinical Trials

21,293 Total Patients Enrolled

David A Cunningham, PhDPrincipal InvestigatorMetroHealth Medical Center

1 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

electrical stimulator (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03857529 — N/A

Rehabilitation Research Study Groups: conventional tDCS concurrent with CCFES, conventional tDCS preceding CCFES, unconventional tDCS preceding CCFES, sham tDCS with CCFES, unconventional tDCS concurrent with CCFES

Rehabilitation Clinical Trial 2023: electrical stimulator Highlights & Side Effects. Trial Name: NCT03857529 — N/A

electrical stimulator (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03857529 — N/A

~4 spots leftby Aug 2026

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