What side effects are associated with this type of intervention?

Common treatments for Primary Progressive Aphasia (PPA) include speech-language therapy and neuromodulatory interventions like Transcranial Direct Current Stimulation (tDCS). tDCS is generally well-tolerated, but some patients may experience mild side effects such as skin irritation at the site of stimulation, headache, dizziness, or a tingling sensation. These side effects are typically transient and resolve shortly after the treatment session. It is important for patients to discuss potential side effects with their healthcare provider to ensure the best possible management of their condition.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Primary Progressive Aphasia (PPA) mentioned in the provided context. However, the context does discuss the potential benefits of neuromodulatory treatments like Transcranial Direct Current Stimulation (tDCS) combined with speech-language telerehabilitation for PPA. These treatments aim to enhance communication skills and quality of life by targeting critical brain networks. While tDCS is being studied for its feasibility and preliminary benefits, it has not yet been established as an FDA-approved treatment for PPA.

What other types of research exist?

Promising novel alternatives to tDCS for PPA patients include Deep Brain Stimulation (DBS) and speech-language telerehabilitation methods. DBS involves the implantation of electrodes to modulate brain activity and has shown potential in various neurological conditions. Speech-language telerehabilitation, which has documented robust benefits, can be enhanced with tailored neuromodulatory interventions targeting critical brain networks.

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Procedure

Speech Therapy + tDCS for Aphasia

N/A

Waitlist Available

Led By Maya Henry, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

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

Must have

Score of 20 or higher on the Mini-Mental State Examination

Meets diagnostic criteria for PPA

Must not have

Contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy)

Speech and language deficits better accounted for by another neurological disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help people with primary progressive aphasia (PPA) by combining home-based brain stimulation with online speech therapy. The brain stimulation uses a gentle electrical current to boost the effects of speech therapy, which may improve communication skills and quality of life for those affected by PPA.

Who is the study for?

This trial is for adults with Primary Progressive Aphasia who can think clearly enough (score of 20+ on a mental state exam), see and hear well (with aids if needed), undergo an MRI, have internet access, and a partner to help them through the study. It's not for those with other neurological issues, history of stroke/epilepsy/severe brain injury, or contraindications for tDCS/MRI.

What is being tested?

The trial tests whether home-based brain stimulation paired with speech-language therapy via video call helps people with different types of PPA. Participants will receive either real or sham brain stimulation while engaging in language exercises designed to improve communication.

What are the potential side effects?

Transcranial Direct Current Stimulation may cause mild side effects like itching, tingling at the electrode site, headache, fatigue or nausea. However, it's generally considered safe and these sensations typically fade after the session.

Eligibility Criteria

Inclusion Criteria

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

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My mental state score is 20 or higher.

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I have been diagnosed with primary progressive aphasia.

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I have been diagnosed with a specific type of primary progressive aphasia.

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I am willing and able to have an MRI scan of my brain.

Exclusion Criteria

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

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I don't have a history of seizures, head injuries, severe migraines, metal implants in my head, chronic skin problems, or a pacemaker. I am not pregnant.

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My speech and language issues are due to a different neurological condition.

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I have had a stroke, epilepsy, or significant brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

RS-LRT arm: Change in spoken naming

RS-VISTA arm: Change in script production accuracy

Secondary study objectives

Care Partner Survey

Change on Aphasia Impact Questionnaire

Change on Communication Confidence Rating Scale for Aphasia

+2 more

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: RS-VISTAExperimental Treatment3 Interventions

Group II: RS-LRTExperimental Treatment3 Interventions

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Primary Progressive Aphasia (PPA) treatments often include speech-language therapy and neuromodulatory interventions like Transcranial Direct Current Stimulation (tDCS). tDCS works by delivering a low electrical current to specific brain regions, modulating neuronal activity to enhance the effects of speech-language rehabilitation. This is particularly important for PPA patients as it targets critical brain networks involved in language processing, potentially prolonging speech-language skills and improving quality of life. Understanding these mechanisms helps tailor treatments to maximize their efficacy and accessibility for patients.