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Device

tDCS for Post-Stroke Motor Impairment

N/A

Recruiting

Research Sponsored by Carle Foundation Hospital

Eligibility Criteria Checklist

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

Must have

Capacity to provide informed consent

Paresis confined to one side, with substantial motor impairment of the paretic upper limb

Must not have

Muscle tone abnormalities and motor or sensory impairment in the non-paretic limb

Severe wasting or contracture or significant sensory deficits in the paretic upper limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

Summary

This trial will test whether two different types of electrical brain stimulation can help people with motor impairments after a stroke.

Who is the study for?

This trial is for stroke survivors with significant motor impairments in one arm, who can consent to treatment. It's not suitable for those with abnormal muscle tone, severe limb wasting or sensory deficits, cognitive issues preventing understanding of the study, serious medical conditions, pacemaker users, metal implants in the head, known adverse reactions to TMS/tDCS or if pregnant.

What is being tested?

The trial tests targeted high-definition transcranial direct current stimulation (THD-tDCS) on reducing upper limb flexion synergy after a stroke. It will inhibit and facilitate specific brain regions to see if this improves motor function by modulating nerve tract excitability.

What are the potential side effects?

Possible side effects of THD-tDCS may include discomfort at the electrode site on the scalp, itching or tingling during stimulation, fatigue post-treatment, headache or nausea. Serious side effects are rare but could involve seizures or skin burns.

Eligibility Criteria

Inclusion Criteria

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

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I understand the details of the clinical trial and can consent to participate.

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I have significant weakness in one arm.

Exclusion Criteria

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

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I have muscle and movement issues in my limb that was not paralyzed.

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My affected arm is very weak or has severe muscle loss.

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I do not have severe mental health issues that affect my understanding or communication.

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I do not have severe health issues like heart or lung problems.

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I have metal implants in my head.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the 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

Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle

Broca Aphasia

Secondary study objectives

Change in Fugl-Meyer Upper Extremity assessment

Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies

Other study objectives

Modified Ashworth Scale

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Bilateral StimulationActive Control1 Intervention

Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere and cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere at the same time.

Group II: Anodal stimulationActive Control1 Intervention

Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.

Group III: Cathodal stimulationActive Control1 Intervention

Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.

Group IV: Sham stimulationPlacebo Group1 Intervention

Sham stimulation to both hemisphere of the brain

0 / 7Eligibility criteria met