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tDCS + Speech Therapy for Aphasia

N/A

Waitlist Available

Led By E. Susan Duncan, PhD, CCC-SLP

Research Sponsored by Louisiana State University and A&M College

Eligibility Criteria Checklist

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

Must have

Not receiving any other speech therapy for the entire study period (20 weeks) (for participants with aphasia)

Be older than 18 years old

Must not have

History of seizure or change in seizure medication in past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

Summary

This trial is studying whether transcranial direct current stimulation (tDCS), when combined with aphasia therapy, can improve language abilities in people who have chronic, post-stroke aphasia.

Who is the study for?

This trial is for right-handed, English-speaking adults with a high school education who had a single-event left hemisphere stroke over 6 months ago and have chronic aphasia. They must not be receiving other speech therapies during the study or have any conditions that would interfere with MRI scans, such as metal implants or pregnancy.

What is being tested?

The study tests if brain stimulation using transcranial direct current stimulation (tDCS) can improve language abilities in people with post-stroke aphasia when combined with verb network strengthening treatment (VNeST). Participants receive weak electrical currents to their scalp twice weekly for 8 weeks during speech therapy sessions.

What are the potential side effects?

Potential side effects of tDCS may include mild tingling, itching, or discomfort at the electrode sites on the scalp. There's also a small risk of fatigue or headache after treatment. Serious side effects are rare but could involve changes in mood or seizure.

Eligibility Criteria

Inclusion Criteria

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

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I am not undergoing any other speech therapy for my aphasia during the study.

Exclusion Criteria

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

Select...

I haven't had seizures or changed seizure medication in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Production of Correct Information Units (CIUs) on Discourse Tasks

Secondary study objectives

Boston Naming Test

Western Aphasia Battery-Revised

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: A-tDCS & speech-language therapyExperimental Treatment2 Interventions

Anodal transcranial direct current stimulation (2 milliamps \[mA\]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes.

Group II: Sham-tDCS & speech-language therapyPlacebo Group2 Interventions

Sham transcranial direct current stimulation (2 milliamps \[mA\]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anodal transcranial direct current stimulation

2016

Completed Phase 3

~180

0 / 2Eligibility criteria met