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Non-invasive Brain Stimulation

Brain Stimulation for Speech Disorders

Phase < 1

Waitlist Available

Led By John Hart, MD

Research Sponsored by The University of Texas at Dallas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 85 years of age

A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech

Must not have

A significant history of arrhythmia or epileptic seizures.

Currently receiving speech-language intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment change from baseline to immediate post, and 8 weeks post treatment completion.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation of the brain can improve speech and language difficulties in patients with primary progressive aphasia or progressive apraxia of speech.

Who is the study for?

This trial is for adults aged 18-85 with primary progressive aphasia or apraxia of speech, who can consent to participate. It's not suitable for those currently in speech therapy, with implanted devices like pacemakers, skull defects, non-native English speakers, a history of seizures or arrhythmias, or if pregnant.

What is being tested?

The study tests if transcranial direct current stimulation (tDCS) on the brain area linked to memory can help improve speech and language issues in patients with aphasia and apraxia of speech. Speech/language functions are primarily measured alongside other cognitive abilities and EEG readings.

What are the potential side effects?

Potential side effects from tDCS may include mild discomfort at the stimulation site, itching or tingling during application, headache, fatigue after treatment sessions. Serious side effects are rare but could involve seizure risk.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 85 years old.

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I have been diagnosed with a specific type of speech disorder.

Exclusion Criteria

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

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I have a history of irregular heartbeats or seizures.

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I am currently getting help from a speech therapist.

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I have a defect in my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment change from baseline to immediate post, and 8 weeks post treatment completion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment change from baseline to immediate post, and 8 weeks post treatment completion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment change from baseline to immediate post, and 8 weeks post treatment completion. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Category Fluency

Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised

The Apraxia battery for Adults - 2 (ABA - 2)

+2 more

Secondary study objectives

The Digit Span Forward & Backward

The Digit Symbol Substitution Test

The Hopkins Verbal Learning Test-Revised

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active tDCS treatmentExperimental Treatment1 Intervention

This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation

2012

Completed Phase 3

~650

0 / 5Eligibility criteria met