10 Participants Needed

TDCS for Spasmodic Dysphonia

Recruiting at 1 trial location
NK
Overseen ByNabin Koirala, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

How does the treatment TDCS differ from other treatments for spasmodic dysphonia?

TDCS (transcranial direct current stimulation) is unique because it is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, potentially offering a new approach compared to the standard botulinum toxin injections, which require repeated administration and can lose effectiveness over time.12345

What is the purpose of this trial?

This project will apply transcranial direct current stimulation (tDCS) to multiple brain areas to evaluate the effects as a potential treatment for laryngeal dystonia (formerly spasmodic dysphonia).

Research Team

NK

Nabin Koirala, PhD

Principal Investigator

Yale University

Eligibility Criteria

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.
See 2 more

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Laryngeal Dystonia (LD) tDCSExperimental Treatment1 Intervention
Adductor, Abductor and Mixed type LD with clinical evaluation of LD or with proof of LD diagnosis

Find a Clinic Near You

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+

Findings from Research

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.
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]

References

Brain activity related to phonation in young patients with adductor spasmodic dysphonia. [2014]
Coagulation of posterior cricoarytenoid muscles for abduction spasmodic dysphonia. [2021]
Botulinum toxin in the treatment of adductor spasmodic dysphonia. [2010]
Neurectomy and Myomectomy for Treatment of Spasmodic Dysphonia. [2022]
Adductor Spasmodic Dysphonia Improves with Bilateral Thalamic Deep Brain Stimulation: Report of 3 Cases Done Asleep and Review of Literature. [2021]
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