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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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Louisiana State University and A&M CollegeLead Sponsor
10 Previous Clinical Trials
1,053 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had seizures or changed seizure medication in the last year.You have a hairstyle that prevents electrodes from touching your scalp.I can do the tasks needed for therapy, even with my speech difficulties.I can do the speaking and MRI tasks needed for the study.You have been diagnosed with aphasia using a specific test called the Western Aphasia Battery-Revised.I have a sensitive scalp, as I've noticed myself.I am not undergoing any other speech therapy for my aphasia during the study.I have no serious medical conditions except for chronic stroke effects if I have aphasia.I had a stroke in the left side of my brain over 6 months ago and have trouble speaking.You cannot have an MRI scan if you have a pacemaker or other specific conditions.I was right-handed before having a stroke.You learned English as your first language and didn't start learning another language before you were 10 years old.
Research Study Groups:
This trial has the following groups:- Group 1: A-tDCS & speech-language therapy
- Group 2: Sham-tDCS & speech-language therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.