TDCS for Spasmodic Dysphonia

Recruiting at 1 trial location

Overseen By Nabin Koirala, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Epilepsy, Depression, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with laryngeal dystonia, a condition that causes voice problems due to muscle spasms in the voice box. Researchers are testing transcranial direct current stimulation (tDCS), which uses a mild electrical current on the brain to see if it can reduce these voice issues. The trial is open to individuals diagnosed with laryngeal dystonia who do not have other speech or voice disorders.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for laryngeal dystonia.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that tDCS is safe for treating laryngeal dystonia?

A previous study found transcranial direct current stimulation (tDCS) to be safe. Most people tolerate tDCS well, experiencing only mild side effects such as tingling or itching on the scalp where the device is applied. Research shows these side effects are temporary and not harmful. No evidence indicates serious side effects from tDCS for laryngeal dystonia, also known as spasmodic dysphonia. This non-invasive treatment does not involve surgery, which generally increases its safety. While more studies are needed to confirm long-term safety, current evidence supports tDCS as a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for spasmodic dysphonia because it offers a non-invasive approach that stands out from current treatments like botulinum toxin injections and voice therapy. Unlike these standard options, tDCS works by delivering a small electrical current to the brain, which can potentially modulate neural activity linked to the vocal cords. This novel mechanism might provide a more consistent and lasting relief from symptoms, with fewer side effects. Additionally, tDCS could be a game-changer in terms of accessibility and ease of use, offering a potential home-based treatment option.

What evidence suggests that tDCS is effective for laryngeal dystonia?

Research has shown that transcranial direct current stimulation (tDCS) might improve symptoms of laryngeal dystonia, also known as spasmodic dysphonia. A review of cases from 2012 to 2020 revealed that three patients with adductor spasmodic dysphonia experienced significant voice improvement after tDCS treatment. Other studies on similar therapies, including tDCS, have reported varying levels of improvement in patients' voice symptoms. These findings suggest that tDCS could be a promising treatment for laryngeal dystonia by targeting specific brain areas involved in voice control. Although more research is needed, the early results are encouraging. ^{1 2 3 4 6}

Who Is on the Research Team?

Nabin Koirala, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with laryngeal dystonia, a voice disorder, who have no other speech or voice disorders and are not pregnant. They must be willing to follow the study procedures for its duration and either have been clinically evaluated for LD or have proof of diagnosis (controls exempted). People with epilepsy, depression, or claustrophobia cannot participate.

Inclusion Criteria

No other known or history of speech, voice disorder other than LD

Provision of signed and dated informed consent form

I am willing and able to follow all study rules and be available for its duration.

Exclusion Criteria

All individuals who do not meet the above mentioned criteria are excluded from the study

Subjects with a history of epilepsy or depression or is claustrophobic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline neuroimaging data acquired via MRI, EEG

1 day

1 visit (in-person)

Treatment

Participants undergo HD-tDCS Stimulation for twenty minutes while watching videos/movies or performing a word production task

5 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TDCS

Trial Overview The trial is testing the Starstim system which delivers transcranial direct current stimulation (tDCS) to brain areas. It aims to assess tDCS as a potential treatment option for laryngeal dystonia by applying it to participants and observing effects.

How Is the Trial Designed?

Group I: Laryngeal Dystonia (LD) tDCS Experimental Treatment 1 Intervention

Adductor, Abductor and Mixed type LD with clinical evaluation of LD or with proof of LD diagnosis

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Spasmodic Dysphonia Association

Collaborator

Trials

3

Recruited

60+

Published Research Related to This Trial

In a review of cases from 2012 to 2020, three patients with adductor spasmodic dysphonia (SD) and essential tremor showed significant improvement in their voice and limb tremors after undergoing bilateral thalamic deep brain stimulation (DBS).

The improvement in SD was specifically noted when higher stimulation amplitudes or wider pulse widths were used, indicating that the effectiveness of DBS for SD may depend on the settings used during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adductor Spasmodic Dysphonia Improves with Bilateral Thalamic Deep Brain Stimulation: Report of 3 Cases Done Asleep and Review of Literature. Evidente, VGH., Ponce, FA., Evidente, MH., et al.[2021]

Citations

1. trialx.com trialx.com/clinical-trials/listings/309824/tdcs-for-laryngeal-dystonia/

tDCS for Laryngeal Dystonia | Clinical Research Trial ... This project will apply transcranial direct current stimulation (tDCS) to multiple brain areas to evaluate the effects as a potential ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10669610/

A Transcranial Magnetic Stimulation Approach - PMC The study's aims are to (1) describe transcranial magnetic stimulation (TMS) methodology for studying the functional integrity of the corticospinal tract.

3. withpower.com withpower.com/trial/phase-dysphonia-2-2025-e1e1e

TDCS for Spasmodic Dysphonia In a review of cases from 2012 to 2020, three patients with adductor spasmodic dysphonia (SD) and essential tremor showed significant improvement in their voice ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199725001110

Neuromodulation for Laryngeal Dystonia: A Systematic ... All included studies reported various degrees of improvement in patients' voice symptoms with the neuromodulation therapy used. ... No significant ...

5. mdpi.com mdpi.com/2077-0383/11/12/3453

A Narrative Review and Two Case Reports Applying TMS ... Previous work using TMS has indicated reduced inhibition to be characteristic of focal laryngeal dystonia (LD), hand dystonia, cervical dystonia, and spasmodic ...

6. medlink.com medlink.com/articles/spasmodic-dysphonia

Laryngeal dystonia (spasmodic dysphonia) Focal vocal cord spasms causing strained or breathy speech during speaking. More common in women, diagnosed through voice evaluation and endoscopy.