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tDCS + Speech Therapy for Aphasia

N/A
Recruiting
Led By Sara Pillay, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be adults and have English-language fluency
Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor)
Must not have
Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 time points: pre-assessment, 10 weeks post-therapy cycle a and 10 weeks post-therapy cycle b
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether adding electrical stimulation to speech therapy can help people with post-stroke aphasia recover language skills.

Who is the study for?
This trial is for adults who have language difficulties due to brain damage like a stroke. They must speak English fluently and be able to undergo an MRI scan. People with advanced neurodegenerative diseases, severe psychiatric conditions, uncorrectable hearing or vision issues, developmental disabilities, or contraindications to MRI are not eligible.
What is being tested?
The study tests if mild electrical stimulation (tDCS) combined with speech therapy can help improve language in people who've had a stroke causing aphasia. There are two types of tDCS being tested alongside two kinds of speech therapies focused on different aspects of language.
What are the potential side effects?
Possible side effects from tDCS may include slight skin irritation under the electrodes, tingling sensations during treatment, fatigue, headache or nausea. However, these tend to be mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult who speaks and understands English fluently.
Select...
I have language difficulties due to a stroke or brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an advanced stage of a brain condition like Alzheimer's, epilepsy, Parkinson's, or ALS.
Select...
I do not have uncorrectable hearing, vision problems, or learning disabilities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 time points: pre-assessment, 10 weeks post-therapy cycle a and 10 weeks post-therapy cycle b
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 time points: pre-assessment, 10 weeks post-therapy cycle a and 10 weeks post-therapy cycle b 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 from baseline language performance on Picture Naming and Reading Tasks
Secondary study objectives
fMRI
Other study objectives
Performance on functional outcome measures assessed through the language battery

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Targeted tDCS with Semantic-Focused Speech TherapyExperimental Treatment2 Interventions
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.
Group II: Targeted tDCS with Phonologic-Focused Speech TherapyExperimental Treatment2 Interventions
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.
Group III: Active Control tDCS with Phonologic-Focused Speech TherapyActive Control2 Interventions
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.
Group IV: Active Control tDCS with Semantic-Focused Speech TherapyActive Control2 Interventions
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Targeted Transcranial Direct Current Stimulation
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,698 Total Patients Enrolled
6 Trials studying Aphasia
340 Patients Enrolled for Aphasia
Sara Pillay, PhDPrincipal Investigator - Medical College of Wisconsin
Medical College of Wisconsin

Media Library

Targeted Transcranial Direct Current Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04166513 — N/A
Aphasia Research Study Groups: Targeted tDCS with Phonologic-Focused Speech Therapy, Active Control tDCS with Phonologic-Focused Speech Therapy, Active Control tDCS with Semantic-Focused Speech Therapy, Targeted tDCS with Semantic-Focused Speech Therapy
Aphasia Clinical Trial 2023: Targeted Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT04166513 — N/A
Targeted Transcranial Direct Current Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166513 — N/A
~2 spots leftby Dec 2029
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