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Behavioral Intervention

HD-tDCS + Speech Therapy for Aphasia

N/A
Recruiting
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 must be 18 or older
Must not have
Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS)
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 look at how mild electricity and speech therapy can help stroke survivors with language issues. #strokerecovery

Who is the study for?
This trial is for adults over 18 with aphasia from left-sided brain damage like a stroke, who can speak English and are MRI-eligible. It's not for those with advanced neurodegenerative diseases, unmanaged seizure disorders, severe mental health issues, major hearing or vision problems, developmental disabilities, or MRI contraindications such as metal implants.
What is being tested?
The study tests if mild electrical stimulation to the brain (HD-tDCS) combined with speech therapy helps language recovery in people who have speech difficulties after a stroke. Participants will receive this combination treatment and their progress will be monitored.
What are the potential side effects?
Possible side effects of HD-tDCS may include discomfort at the electrode site on the head, itching or tingling during stimulation, headache, fatigue and in rare cases nausea. Speech therapy typically does not have physical side effects.

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.
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I am 18 years old or older.
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I have difficulty with language due to a stroke or tumor on the left side of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological condition like epilepsy, Parkinson's, or ALS.
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I have hearing, vision difficulties, or a learning disability that cannot be corrected.
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I have advanced Alzheimer's disease.
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I am either younger than 18 or older than 85.

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
Behavioral outcome
Secondary study objectives
fMRI

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Speech TherapyExperimental Treatment1 Intervention
Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy
Group II: HD-tDCSExperimental Treatment1 Intervention
Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Speech Therapy
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
628 Previous Clinical Trials
1,179,676 Total Patients Enrolled
~133 spots leftby Jan 2033