Laryngeal DystoniaNCT06830174
tDCS for Laryngeal Dystonia
A study testing Starstim system in people with Laryngeal Dystonia, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngeal Dystonia
- What is being tested?
- Starstim system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06511
Nabin Koirala, PhD, 203-785-2527, nabin.koirala@yale.edu
About this study
Official title: Network Targeted Transcranial Direct Current Stimulation (tDCS) as a Treatment for Laryngeal Dystonia (LD)
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).
Read the detailed description
Baseline neuroimaging data will be acquired from all participants via MRI, EEG. Each participant will be seen for multiple testing sessions over a five day period. LD participants will undergo the neuromodulation (HD-tDCS Stimulation) for twenty minutes while engaged in watching videos/movies or performing a word production task.
- Conditions
- Laryngeal Dystonia
- Being tested
- Starstim system
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starstim systemDevice
Transcranial direct current stimulation (tDCS)
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Dystonia (LD) tDCS | Experimental | Adductor, Abductor and Mixed type LD with clinical evaluation of LD or with proof of LD diagnosis Receives: Device: Starstim system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: daily on Day 1-Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start14 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DystoniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Spasmodic Dysphonia Association
- Responsible party
- Sponsor
- Investigators
- Nabin Koirala, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830174
- Sponsor's protocol ID
- 2000032414
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Investigators do not have consent for patients for sharing their data yet, if that changes, de-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Targeted Transcranial Direct Current Stimulation (tDCS) as a Treatment for Laryngeal Dystonia (LD)
- ClinicalTrials.gov ID
- NCT06830174
- Acronym / sponsor ID
- 2000032414
- Conditions
- Laryngeal Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Spasmodic Dysphonia Association
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Baseline neuroimaging data will be acquired from all participants via MRI, EEG. Each participant will be seen for multiple testing sessions over a five day period. LD participants will undergo the neuromodulation (HD-tDCS Stimulation) for twenty minutes while engaged in watching videos/movies or performing a word production task.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Dystonia (LD) tDCS | Experimental | Device: Starstim systemAdductor, Abductor and Mixed type LD with clinical evaluation of LD or with proof of LD diagnosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starstim systemTranscranial direct current stimulation (tDCS) | Device | Laryngeal Dystonia (LD) tDCS |
Primary outcome
Change in Cepstral peak prominence (CPP)
Time frame: daily on Day 1-Day 5
Cepstral peak prominence (CPP) as a robust objective measure of voice quality in the active, sham and no stimulation conditions.
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Time frame: daily on Day 1-Day 5
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. Investigators do not have consent for patients for sharing their data yet, if that changes, de-identified data will be shared.
Related trials for Laryngeal Dystonia
Not yet recruiting
EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
Spasmodic Dysphonia
Not yet recruiting
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Presbylarynx, Aspiration
RecruitingObservational study
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia
Not yet recruiting
Transcranial Magnetic Stimulation in Laryngeal Dystonia
Laryngeal Dystonia, Spasmodic Dysphonia
Not yet recruitingPhase 1
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
Spasmodic Dysphonia, Laryngeal Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabin Koirala, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starstim system in people with Laryngeal Dystonia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabin Koirala, PhD (203 7852527, nabin.koirala@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cepstral peak prominence (CPP) (time frame: daily on Day 1-Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.