Actively Recruiting

Phase Not Applicable
Age: 21Years - 85Years
All Genders
Healthy Volunteers
ID05095740

The Effects of Neuromodulation on Phonatory Function in Laryngeal Dystonia

Led by MGH Institute of Health Professions · Updated on 2026-02-20

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

MGH Institute of Health Professions

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Laryngeal dystonia (LD) is a condition that causes excessive opening or closing of the vocal folds, leading to problems with voice quality, job prospects, self-worth, and overall quality of life. People with LD often experience symptoms like breathy voice, pitch breaks, and vocal tremor. While brain imaging has shown differences in brain areas related to voice control, the exact brain function behind LD is not fully understood. Current treatments like voice therapy and Botox injections provide temporary relief but have limitations. This research aims to study a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) to better understand and potentially improve brain control of voice muscles in LD. The study will compare 5 days of daily rTMS treatment targeting the left laryngeal motor cortex with a sham (placebo) rTMS treatment. Participants will receive about 20 minutes of rTMS each day using a specialized coil to stimulate brain areas responsible for voice muscle control. The sham treatment mimics the sensation and sound without actual brain stimulation. After the initial 5-day treatment and assessments, participants will cross over to receive the other treatment after at least 3 months. The study will measure voice changes and brain responses before and after each treatment phase. Participants will undergo detailed voice assessments, including listening tests, acoustic analysis, and self-reported voice effort ratings. Brain activity will be measured using a specialized neurophysiology assessment involving fine-wire electrodes inserted into voice muscles and brain stimulation tests to evaluate muscle control. Safety screenings will be done before treatments. Researchers will track changes in voice function and brain excitability at baseline, after treatment, and follow-up times. The total involvement includes initial screening, two treatment phases with assessments, and a follow-up period lasting several months.

CONDITIONS

Brief Title

Effects of Neuromodulation in Laryngeal Dystonia

Who Can Participate

Age: 21Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 21 and 85 years
  • Diagnosis of laryngeal dystonia (LD)
  • Ability to give informed consent
  • Symptoms at worst severity if receiving botulinum toxin injections
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Presence of other forms of dystonia
  • Vocal fold pathology or paralysis
  • Essential tremor
  • Laryngeal cancer or other neurological conditions with central nervous system medications
  • History of laryngeal surgery
  • Inability to consent or complete study procedures
  • Seizure within the last 2 years
  • Contraindications to rTMS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants undergo baseline acoustic, perceptual, patient-reported voice assessments, and neurophysiologic testing including TMS measurement of cortical excitability and inhibition.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive 5 consecutive days of real or sham repetitive transcranial magnetic stimulation (rTMS) targeting the left laryngeal motor cortex to assess effects on phonatory function.

Daily visits for 5 consecutive days

Post-Treatment Assessment

Duration - 1 day

After the 5-day rTMS intervention, participants undergo repeat acoustic, perceptual, patient-reported voice assessments, and neurophysiologic testing.

1 visit (in-person)

Follow-up

Duration - 7 days after post-treatment

Participants are assessed approximately one week after treatment for changes in phonatory function and self-ratings of voice effort.

1 visit (in-person)

Crossover Phase

Duration - Approximately 3 months later plus 7 days for assessments

At least 3 months after initial treatment, participants receive the alternate intervention (real or sham rTMS) following the same schedule of baseline assessment, 5-day treatment, post-treatment assessment, and follow-up.

Multiple visits including baseline, 5 daily treatment visits, post-treatment, and follow-up visits

Trial Site Locations

Total: 1 location

1

Teresa J Kimberley

Boston, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

C

Caitlin Koehler, Lab Manager

T

Teresa J Kimberley, PhD, PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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