What side effects are associated with this type of intervention?

The most common treatments for Primary Progressive Aphasia (PPA) include speech and language therapy, pharmacological interventions, and neuromodulation techniques such as Transcranial Direct Current Stimulation (tDCS). tDCS, which modulates neuronal activity to enhance language performance, is generally well-tolerated but can cause mild side effects such as skin irritation at the electrode site, headache, dizziness, and a tingling sensation. Pharmacological treatments, like cholinesterase inhibitors, may cause gastrointestinal issues, insomnia, and muscle cramps. Speech and language therapy typically has no adverse effects but requires consistent effort and participation from patients.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Primary Progressive Aphasia (PPA) that are mentioned in the provided context. However, treatments being studied for PPA include neuromodulation techniques such as Transcranial Direct Current Stimulation (tDCS), which aims to enhance language performance by modulating neuronal activity. Other pharmacological treatments for related conditions, such as Alzheimer's disease, include memantine and cholinesterase inhibitors, but their efficacy for PPA specifically is not well-established.

What other types of research exist?

Promising novel alternatives to tDCS for Primary Progressive Aphasia (PPA) patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown potential in improving language functions by modulating cortical activity. 2) Deep Brain Stimulation (DBS), although primarily used for movement disorders, is being explored for its effects on language and cognitive functions. 3) Vagus Nerve Stimulation (VNS), which has demonstrated some efficacy in enhancing neuroplasticity and cognitive functions. These alternatives are still under investigation, and their use should be discussed with a healthcare provider.

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Behavioral Intervention

tDCS + mCILT for Primary Progressive Aphasia

N/A

Waitlist Available

Led By Roy Hamilton, MS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Presence of aphasia attributable to the semantic variant (svPPA) or non-fluent/agrammatic variant (naPPA) of Primary Progressive Aphasia

Must be a native English speaker

Must not have

Subjects with previous craniotomy or any breach in the skull

Subjects with a history of small vessel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Summary

This trial tests a new treatment combining brain stimulation and intensive language therapy for people with specific types of progressive language disorders. The goal is to see if this combination can improve their language skills more effectively than therapy alone. Researchers will also study brain scans to understand how the treatment works and who might benefit the most. Brain stimulation has been studied for its potential to enhance language recovery, often showing promise when combined with traditional language therapy.

Who is the study for?

This trial is for native English speakers with a specific language disorder called Primary Progressive Aphasia, either the semantic or non-fluent/agrammatic variant. It's not suitable for people with pacemakers, history of small vessel disease, other neurological disorders like stroke or Parkinson's, seizures, metallic objects in the head (except dental work), or those who've had skull surgery.

What is being tested?

The study tests if brain stimulation using tDCS combined with a type of language therapy (mCILT) can help improve speech in people with PPA. Participants will receive real or fake tDCS over 10 days and have their language skills and brain function assessed before and after treatment, up to 24 weeks later.

What are the potential side effects?

tDCS may cause mild side effects such as itching, tingling at the electrode site during application, headache, fatigue or nausea. However, these are typically temporary and resolve soon after treatment.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of language disorder due to Primary Progressive Aphasia.

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I am a native English speaker.

Exclusion Criteria

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

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I have had surgery on my skull.

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I have a history of small vessel disease.

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I have a history of neurological disorders like stroke or Parkinson's.

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I have had seizures or unexplained fainting episodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Western Aphasia Battery (WAB)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: tDCS + CILTActive Control2 Interventions

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will participate in a modified constraint-induced language therapy.

Group II: Sham tDCS + CILTPlacebo Group2 Interventions

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathose is placed over O1. Subjects will participate in a modified constraint-induced language therapy,

0 / 6Eligibility 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

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies a low electrical current to the scalp to modulate neuronal activity. When paired with language therapy, such as modified constraint-induced language therapy (mCILT), tDCS can enhance language performance by promoting neuroplasticity and improving functional connectivity in language-related brain networks. This is particularly important for PPA patients, as it offers a potential method to slow the progression of language deficits and improve communication abilities, thereby enhancing their quality of life.