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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
Ability to perform the required therapy tasks (determined via in-person screening) (for participants with aphasia)
Ability to perform the required discourse and MRI tasks (determined via in-person screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can do the tasks needed for therapy, even with my speech difficulties.
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I can do the speaking and MRI tasks needed for the study.
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I am not undergoing any other speech therapy for my aphasia during the study.
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I had a stroke in the left side of my brain over 6 months ago and have trouble speaking.
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I was right-handed before having a stroke.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Production of Correct Information Units (CIUs) on Discourse Tasks
Secondary outcome measures
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
~130

Find a Location

Who is running the clinical trial?

Louisiana State University and A&M CollegeLead Sponsor
8 Previous Clinical Trials
509 Total Patients Enrolled
1 Trials studying Aphasia
7 Patients Enrolled for Aphasia
E. Susan Duncan, PhD, CCC-SLPPrincipal InvestigatorLouisiana State University Health Sciences Center in New Orleans
1 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Aphasia
7 Patients Enrolled for Aphasia

Media Library

Speech-Language Therapy (SLT) Clinical Trial Eligibility Overview. Trial Name: NCT04142866 — N/A
Aphasia Research Study Groups: A-tDCS & speech-language therapy, Sham-tDCS & speech-language therapy
Aphasia Clinical Trial 2023: Speech-Language Therapy (SLT) Highlights & Side Effects. Trial Name: NCT04142866 — N/A
Speech-Language Therapy (SLT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04142866 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for volunteers to join this research experiment?

"The information posted on clinicaltrials.gov suggests that this medical study is no longer recruiting patients, despite having been initially listed on September 1st 2022 and most recently updated April 8th 2022. Nevertheless, there are presently 1099 other trials actively searching for eligible participants."

Answered by AI

Who is an eligible candidate for this clinical investigation?

"This research is looking for approximately 30 individuals between the ages of 21 and 80 who have experienced a stroke. Those interested must meet these criteria in order to qualify for inclusion."

Answered by AI

Is the age restriction for this research study limited to individuals over 20 years old?

"The age bracket for enrollment into this medical trial is 21 to 80, as indicated by its inclusion criteria."

Answered by AI
~20 spots leftby Dec 2024