tDCS + Physical Therapy for Stroke Recovery (TRANSPORT 2 Trial)

Palo Alto (17 mi)

Overseen byWayne Feng, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Duke University

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No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Eligibility Criteria

This trial is for adults aged 18-80 who've had their first ischemic stroke within the last 30-180 days, leading to arm weakness but still retain some movement. They must be stable in their motor impairment and have a reasonable pre-stroke level of independence. Excluded are those with severe cognitive issues, other neurological disorders, certain metal implants or injuries, uncontrolled conditions like hypertension, or use of interfering medications.

Inclusion Criteria

I have weakness in one arm with a moderate level of impairment.

I am between 18 and 80 years old.

I was mostly independent before my stroke.

I can move my wrist, thumb, and fingers more than 10 degrees.

Exclusion Criteria

I have had a Botulinum toxin injection in my arm in the last 3 months.

I have a condition affecting my arm or hand movement.

I do not have any neurological disorders that would prevent me from participating in the study.

I have had a stroke or bleeding in my brain.

Treatment Details

The study tests three doses of transcranial direct current stimulation (tDCS), which uses electrical currents to stimulate the brain after a stroke. It's paired with modified Constraint-Induced Movement Therapy (mCIMT) where participants use their weaker arm while the stronger one is restrained to improve arm function.

3Treatment groups

Active Control

Placebo Group

Group I: 2 mA tDCS + mCIMTActive Control2 Interventions

2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Group II: 4 mA + mCIMTActive Control2 Interventions

4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Group III: Sham tDCS + mCIMTPlacebo Group2 Interventions

Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)