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Procedure

tACS for Aphasia After Stroke

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

Diagnosed with left hemisphere stroke/aphasia

18 years of age or older

Must not have

A chronic medical condition that is not treated or is unstable

History of ongoing or unmanaged seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Summary

This trial looks at how electrical stimulation to the brain can help stroke survivors regain language abilities.

Who is the study for?

This trial is for English-speaking adults over 18 who have had a stroke affecting the left side of their brain, leading to aphasia. They must be at least one month post-stroke. People with severe sensory impairments, untreated psychiatric diseases, unstable medical conditions, pacemakers or cardiac stimulators, seizure disorders, dyslexia or learning disabilities cannot participate.

What is being tested?

The study is testing whether transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique, can help improve short-term memory for words in people who have language difficulties after a stroke. Some participants will receive real tACS while others get sham (fake) treatment as a comparison.

What are the potential side effects?

Possible side effects from tACS may include mild headaches, tingling on the scalp where electrodes are placed, fatigue shortly after treatment sessions and in rare cases light-headedness or nausea.

Eligibility Criteria

Inclusion Criteria

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

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I had a stroke that affected the left side of my brain.

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I am 18 years old or older.

Exclusion Criteria

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

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I have a chronic condition that is not being treated or is unstable.

Select...

I have seizures that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Accuracy on a phonological STM task

fMRI measures of language network activation after tACS

Secondary study objectives

Functional Communication Outcome

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High Definition tACS with Short-term Memory Focused Speech TherapyExperimental Treatment1 Intervention

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages.The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS stimulation for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes. This will be paired with short-term memory focused speech therapy.

Group II: Sham-High Definition tACS with Short-term Memory Focused Speech TherapyPlacebo Group1 Intervention

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups. This will be paired with short-term memory focused speech therapy.

0 / 4Eligibility criteria met