What side effects are associated with this type of intervention?

Common treatments for aphasia include speech-language therapy, repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (TDCS). Speech-language therapy generally has minimal side effects but may cause frustration or fatigue. rTMS can lead to headaches, scalp discomfort, and, rarely, seizures. TDCS, which modulates neuronal activity to improve language function, is generally well-tolerated but can cause mild side effects such as tingling, itching, or redness at the stimulation site, as well as headaches and dizziness. These side effects are typically transient and mild.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for aphasia that involve Transcranial Direct Current Stimulation (TDCS) targeting the right Inferior Frontal Gyrus. However, TDCS is being studied as a potential treatment to enhance language function in individuals with chronic post-stroke aphasia. Current treatments for aphasia primarily focus on speech-language therapy, and while neuromodulation techniques like TDCS show promise, they remain experimental and are not yet standard clinical practice.

What other types of research exist?

Promising, novel alternatives to TDCS for aphasia patients include Transcranial Magnetic Stimulation (TMS) and Deep Brain Stimulation (DBS). TMS is non-invasive and has shown potential in cognitive enhancement, while DBS, though more invasive, has demonstrated significant improvements in treatment-resistant neurological conditions.

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tDCS + Speech-Language Therapy for Aphasia (AphasiatDCS Trial)

N/A

Recruiting

Led By Jessica Richardson, Ph.D.

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Aged 25-85

Must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production

Must not have

Comorbid neurological disease

Damage to the anterior right hemisphere

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Summary

This trial uses a non-invasive brain stimulation technique combined with speech therapy to help stroke patients with Aphasia improve their communication skills. The brain stimulation aims to enhance the effects of language therapy by making the brain's language areas work better together. This technique has shown promise in improving language recovery in post-stroke aphasia.

Who is the study for?

This trial is for individuals aged 25-85 who are more than a year post-stroke and have aphasia, which affects their language abilities. They must show left-hemisphere brain damage and be responsive to naming tasks. People with other neurological diseases, right hemisphere damage, mood disorders, recent substance abuse, electrical implants that interfere with tDCS or MRI scans, medical instability or pregnancy cannot participate.

What is being tested?

The study tests if targeted Transcranial Direct Current Stimulation (tDCS) can improve speech-language therapy outcomes in people with chronic aphasia after a stroke. Participants will receive either active cathodal tDCS or placebo alongside language training for 15 days to see which is more effective.

What are the potential side effects?

While the document doesn't specify side effects of tDCS in this context, common ones may include mild itching, tingling at the electrode site during stimulation, headache or fatigue afterwards. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 85 years old.

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I have been diagnosed with aphasia.

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.

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I have damage to the front right part of my brain.

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I do not have any implanted electrical devices and can undergo tDCS or MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Naming Efficiency of trained items

Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)

Picture Naming of trained items

Secondary study objectives

Discourse informativeness - Main Concept Production

Efficiency of discourse informativeness - Main Concept Production

Naming Efficiency of untrained items - Boston Naming Test

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Experimental: Active cathodal tDCS + Speech-language trainingActive Control1 Intervention

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.

Group II: Comparator: Placebo cathodal tDCS + Speech-language trainingPlacebo Group1 Intervention

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..

0 / 5Eligibility 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 noninvasive neuromodulation technique that applies a low electrical current to specific brain regions, such as the right Inferior Frontal Gyrus, to modulate neuronal activity. This stimulation can enhance synaptic plasticity and improve language function, which is crucial for aphasia patients who have impaired language abilities due to brain injury. By targeting areas involved in language processing, tDCS can facilitate better communication skills and overall cognitive function, offering a promising adjunct to traditional speech-language therapy.

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Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

361 Previous Clinical Trials

182,008 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,840 Previous Clinical Trials

8,172,573 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

299 Previous Clinical Trials

248,977 Total Patients Enrolled

University of New MexicoLead Sponsor

388 Previous Clinical Trials

3,526,553 Total Patients Enrolled

Jessica Richardson, Ph.D.4.796 ReviewsPrincipal Investigator - University of New Mexico

Aventura Hospital and Medical Center, Doctors Hospital, Mercy Hospital, South Miami Hospital, Jackson North Medical Center, Jackson South Community Hospital

Medical School - University of Miami, Doctor of Medicine

University of Hawai‘i, Residency in Orthopedic Surgery

5Patient Review

From the moment we walked into the office to the moment we left, everything was excellent. The staff was great and Dr. Brusovanik was wonderful. He took his time to listen to my and explained everything in detail. I would highly recommend him to everyone.