What side effects are associated with this type of intervention?

Common treatments for Apraxia of Speech, particularly those involving neural stimulation like Transcranial Direct Current Stimulation (tDCS), generally have mild side effects. These can include sensations of tingling, itching, or mild discomfort at the site of stimulation. Other potential side effects are headaches, dizziness, and skin redness. Serious adverse effects are rare, making tDCS a relatively safe option for facilitating motor learning in speech rehabilitation.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Apraxia of Speech. However, treatments involving neural stimulation, such as Transcranial Direct Current Stimulation (tDCS), are being explored for their potential to enhance motor learning and speech rehabilitation. These approaches are still under investigation and have not yet received FDA approval for this specific condition.

What other types of research exist?

Promising alternatives to tDCS for Apraxia of Speech patients include repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Magnetic Stimulation (TMS). rTMS has shown potential in modulating cortical activity and improving language functions in various speech and language disorders. Additionally, Transcutaneous Supraorbital Nerve Stimulation (tSNS) has shown benefits in other neurological conditions and may be explored for speech rehabilitation.

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Non-invasive Brain Stimulation

tDCS for Speech Impairment After Stroke

N/A

Recruiting

Led By Adam Buchwald, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of apraxia of speech

A minimum of six months post-stroke

Must not have

Past history of seizures or unexplained spells of loss of consciousness.

Diagnosis of laryngeal voice disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Summary

This trial is testing whether combining a gentle brain stimulation technique called tDCS with regular speech therapy can better help people who have trouble speaking due to brain injury. tDCS uses a mild electrical current to help the brain learn and adapt, which has been successful in other types of stroke recovery. tDCS has been shown to be effective in improving language recovery in post-stroke aphasia.

Who is the study for?

This trial is for right-handed, English-speaking individuals who have had a stroke at least six months ago and now have apraxia of speech. They must not have any voice disorders, other speech impairments from before the stroke, or risk factors that make tDCS unsafe like skin damage where the device goes, implants affected by electricity or magnets, metal inside their body, or a family history of epilepsy.

What is being tested?

The study tests if adding brain stimulation with a Soterix low-intensity stimulator to regular speech therapy helps recovery in people with speech issues after a stroke. Some participants will get real stimulation (tDCS), while others receive sham treatment as a comparison; this is decided randomly.

What are the potential side effects?

tDCS is generally safe and well-tolerated. Possible side effects include mild tingling on the scalp, slight itching under the electrode site during stimulation, brief headache or fatigue post-treatment. Serious risks are rare but can involve seizures.

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 apraxia of speech.

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It has been at least 6 months since my stroke.

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I had a stroke in the left side of my brain.

Exclusion Criteria

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

Select...

I have had seizures or unexplained fainting spells.

Select...

I have been diagnosed with a voice disorder affecting my larynx.

Select...

I have damaged skin where the stimulation device would be placed.

Select...

I have difficulty speaking clearly.

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I had speech problems before my stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 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

Change in accuracy in recordings from tasks from baseline to post treatment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active StimulationExperimental Treatment2 Interventions

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

Group II: Sham StimulationPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham

2013

Completed Phase 3

~2090

0 / 8Eligibility 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 treatment that delivers low-intensity electrical currents to the scalp, aiming to enhance neural plasticity and facilitate motor learning. This mechanism is particularly relevant for Apraxia of Speech (AOS) patients, as it can improve the brain's ability to reorganize and strengthen the neural pathways involved in speech production. By combining tDCS with effective behavioral speech therapy, patients may experience improved speech motor control and communication abilities, which are critical for their daily interactions and overall quality of life.