taVNS for Apraxia of Speech

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist individuals with apraxia of speech, a condition that often makes speaking difficult after a stroke or brain injury. The study explores whether taVNS (transcutaneous auricular vagus nerve stimulation), which stimulates a nerve in the ear, can enhance speech recovery. Participants will engage in activities and treatments over 17 weeks, with some receiving a placebo (a non-active treatment) for comparison. Individuals who have experienced speech problems for at least six months following a stroke or brain injury may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatments for speech recovery.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that influence key neurotransmitters, so you may need to stop taking such medications to participate.

What prior data suggests that this method is safe for improving speech recovery in apraxia of speech?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), a device used to gently stimulate the ear area, is generally safe and well-tolerated. Most side effects, such as skin irritation, headaches, or a sore throat, are mild and resolve quickly. This non-invasive method, which does not involve surgery or entering the body, enhances safety. Additionally, taVNS is affordable and easy to access, making it a promising option for aiding speech recovery in conditions like apraxia of speech.12345

Why are researchers excited about this trial?

Researchers are excited about taVNS for apraxia of speech because it offers a non-invasive way to stimulate the vagus nerve, potentially enhancing speech therapy outcomes. Unlike traditional treatments that rely solely on speech exercises and therapy, taVNS uses mild electrical stimulation to the ear, which may improve brain function related to speech. This innovative approach could provide a complementary boost to standard interventions, offering new hope for individuals struggling with apraxia of speech.

What evidence suggests that taVNS is effective for apraxia of speech?

This trial will compare non-invasive vagus nerve stimulation (taVNS) with a sham stimulation. Studies have shown that taVNS can improve movement and mental health, especially in stroke survivors. One study found that taVNS significantly increased muscle strength compared to a delayed version of the treatment. Research also suggests that taVNS can enhance cognitive function in conditions affecting the brain and mind. Additionally, taVNS has been linked to better performance in tasks requiring idea-switching. These findings suggest that taVNS might aid in speech recovery for individuals with apraxia of speech.26789

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are at least 6 months past a stroke or brain injury and have speech difficulties like apraxia of speech or production-type aphasia. Participants must be native English speakers or bilingual, and cannot join if they have other major neurological issues, trouble understanding language, or take certain medications.

Inclusion Criteria

It has been at least 6 months since my stroke or brain injury.
I have been diagnosed with production type aphasia or apraxia of speech.
I am between 18 and 80 years old.
See 1 more

Exclusion Criteria

Additional cognitive or neurological impairments (Autism, schizophrenia, seizures, etc)
Language comprehension deficits
I am taking medications that affect brain chemicals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive non-invasive vagus nerve stimulation or sham stimulation alongside standard intervention for speech recovery

16 weeks
5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • taVNS

Trial Overview

The study tests whether a device called taVNS (transcutaneous auricular vagus nerve stimulation) can help improve speech in people with acquired apraxia of speech. Some participants will get real taVNS while others receive a sham (inactive) version as a comparison over about 16 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment AExperimental Treatment1 Intervention
Group II: Treatment BPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Eric Sorenson Motor Speech Program at Brooks Rehabilitation

Collaborator

Citations

Transcutaneous auricular vagus nerve stimulation may ... - PMC

Evidence from the included studies suggests that taVNS may improve cognitive performance in neuropsychiatric disorders. The underlying ...

Effectiveness of transcutaneous auricular vagus nerve ...

The results showed that the forelimb muscle strength recovery rate reached 85.9% ± 6.1% in the paired VNS group, 42.1% ± 8.0% in the delayed VNS group, and only ...

The Effect of Transcutaneous Vagus Nerve Stimulation on ...

The authors predicted that the use of VNS during speech therapy could improve outcomes of individuals with receptive language deficits. However, traditional ...

A trial investigating the effectiveness of transcutaneous ...

This study is testing a new potential treatment for misophonia called transcutaneous Vagal Nerve Stimulation (tVNS). tVNS is a safe and non- ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34043386/

The effects of transcutaneous auricular vagal nerve ...

Conclusions: taVNS may improve cognition, particularly executive function, and stimulation parameters may differentially influence outcomes. Continued research ...

Impact of Transcutaneous Vagal Nerve Stimulation (Tvns) ...

TVNS is a low cost, safe, accessible modality with the potential to improve aphasia outcomes, but further work is needed to identify if and how it can be best ...

A pooled analysis of the side effects of non-invasive ...

(2018) concluded that taVNS is generally well-tolerated with mild side effects like skin irritation, headaches, and nasopharyngitis. However, ...

Safety of transcutaneous auricular vagus nerve stimulation ...

The author concluded that transcutaneous vagus nerve stimulation is well tolerated and safe, with only mild side effects such as local skin ...

Efficacy and Safety of Transcutaneous Auricular Vagus ...

Patients will receive TaVNS stimulation for 30 minutes, twice a day (between 9:00 to 10:00 and 15:00 to 16:00), for 7 consecutive days. Stimulation pulses (30 ...