Recruiting

Neuromodulation

Sponsor:

MGH Institute of Health Professions

Code:

NCT05095740

Conditions

Laryngeal Dystonia

Focal Dystonia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS)

sham rTMS

Study Details

Brief summary:

Laryngeal dystonia (LD) causes excessive vocal fold abduction (opening) or adduction (closing) leading to decreased voice quality, job prospects, self-worth and quality of life. Individuals with LD often experience episodic breathy voice, decreased ability to sustain vocal fold vibration, frequent pitch breaks and in some cases, vocal tremor. While neuroimaging investigations have uncovered both cortical organization and regional connectivity differences in structures in parietal, primary somatosensory and premotor cortices of those with LD, there remains a lack of understanding regarding how the brains of those with LD function to produce phonation and how these might differ from those without LD. Intervention options for people with LD are limited to general voice therapy techniques and Botulinum Toxin (Botox) injections to the posterior cricoarytenoid (PCA) and/or TA (thyroarytenoid) often bilaterally, to alleviate muscle spasms in the vocal folds. However, the effects of injections are short-lived, uncomfortable, and variable. To address this gap, the aim of this study is to investigate the effectiveness of repetitive transcranial magnetic stimulation (rTMS), a non-invasive neuromodulation technique, in assessing cortical excitability and inhibition of laryngeal musculature. Previous work conducted by the investigator has demonstrated decreased intracortical inhibition in those with adductor laryngeal dystonia (AdLD) compared to healthy controls. The investigators anticipate similar findings in individuals with with other forms of LD, where decreased cortical inhibition will likely be noted in the laryngeal motor cortex. Further, following low frequency (inhibitory) rTMS to the laryngeal motor brain area, it is anticipated that there will be a decrease in overactivation of the TA muscle. To test this hypothesis, a proof-of-concept, randomized study to down-regulate cortical motor signal to laryngeal muscles will be compared to those receiving an equal dose of sham rTMS. Previous research conducted by the investigator found that a single session of the proposed therapy produced positive phonatory changes in individuals with AdLD and justifies exploration in LD.

Conditions

Laryngeal Dystonia

Focal Dystonia

Study ID

NCT05095740

Start date

Jun 10, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range is 21-85 years
  • Diagnosis of Laryngeal Dystonia (LD)
  • Subject is able to give informed consent
  • Symptoms at worst severity if receiving botulinum toxin injections
  • Subject has signed the consent form

Exclusion Criteria:

  • Other forms of dystonia
  • Vocal fold pathology or paralysis
  • Essential tremor
  • Laryngeal cancer or other neurologic conditions with medications affecting the central nervous system
  • History of laryngeal surgery
  • Adults lacking the ability to consent or complete the assessments and intervention
  • Seizure in the last 2 years
  • Contraindications to rTMS

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: repetitive transcranial magnetic stimulation (rTMS)

5 consecutive days of rTMS to the individualized, targeted, left laryngeal motor cortex associated with laryngeal function to down-regulate cortical motor signal to intrinsic laryngeal muscles and improve vocal function of individuals with LD.

sham comparator: Sham rTMS

5 consecutive days of sham rTMS to the individualized, targeted, left laryngeal motor cortex associated with laryngeal function to down-regulate cortical motor signal to intrinsic laryngeal muscles and improve vocal function of individuals with LD.

Interventions

repetitive transcranial magnetic stimulation (rTMS)

Repetitive transcranial magnetic stimulation used to regulate the contribution of the laryngeal motor cortex to voice production and laryngeal motor muscle activation.

sham rTMS

Repetitive transcranial magnetic stimulation used to a cortical area not associated with change in outcomes at an intensity substantially lower than that of the established threshold.

Primary outcome measure

  • Change in Objective Assessment of Phonatory Function [ Time Frame: Day 1 (baseline), day 5 (post intervention), and Day 12 (follow up) timepoints for both arms of the study. ]
  • Change in Cortical Excitability (intrahemispheric inhibition) [ Time Frame: Day 1 (baseline), Day 5 (post intervention) ]

Central Contacts and Locations

Central contacts

Caitlin Koehler, Lab Manager

617-643-6564brainrecoverylab@mghihp.edu

Teresa J Kimberley, PhD, PT

617-643-9237tkimberley@mgh.harvard.edu

Locations

Teresa J Kimberley

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Teresa J Kimberley, PT, PhD

16176439237tkimberley@mghihp.edu

Principal Investigator:

Teresa J Kimberley, PhD, PT

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • transcranial magnetic stimulation
  • randomized control trial
  • rTMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2026-02-20.