tDCS for Laryngeal Dystonia

NCT06830174 | Recruiting FDA Device

• 1 other identifier: 2000032414
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Laryngeal Dystonia

Outcome Measures

Primary Outcomes (2)

• Change in Cepstral peak prominence (CPP)

  Cepstral peak prominence (CPP) as a robust objective measure of voice quality in the active, sham and no stimulation conditions.

  daily on Day 1-Day 5

• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

  Its primary purpose is to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians

  daily on Day 1-Day 5

Study Arms (1)

Laryngeal Dystonia (LD) tDCS

EXPERIMENTAL

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

Device: Starstim system

Interventions

Starstim system DEVICE

Transcranial direct current stimulation (tDCS)

Laryngeal Dystonia (LD) tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be clinically evaluated for the diagnosis of LD or have the proof of LD diagnosis. (Not applicable for control participants)
• No other known or history of speech, voice disorder other than LD.
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Must not be pregnant.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Spasmodic Dysphonia Association: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nabin Koirala, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabin Koirala, PhD

CONTACT

203 7852527; nabin.koirala@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects and staff will be blind during the study and that subjects will be told of their assignment at the follow-up visit.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)