RECRUITING

Effects of Neuromodulation in Laryngeal Dystonia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Neuromodulation on Phonatory Function in Laryngeal Dystonia

Quick Facts

Study Start:2021-06-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05095740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age range is 21-85 years
  2. * Diagnosis of Laryngeal Dystonia (LD)
  3. * Subject is able to give informed consent
  4. * Symptoms at worst severity if receiving botulinum toxin injections
  5. * Subject has signed the consent form
  1. * Other forms of dystonia
  2. * Vocal fold pathology or paralysis
  3. * Essential tremor
  4. * Laryngeal cancer or other neurologic conditions with medications affecting the central nervous system
  5. * History of laryngeal surgery
  6. * Adults lacking the ability to consent or complete the assessments and intervention
  7. * Seizure in the last 2 years
  8. * Contraindications to rTMS

Contacts and Locations

Study Contact

Caitlin Koehler, Lab Manager
CONTACT
617-643-6564
brainrecoverylab@mghihp.edu
Teresa J Kimberley, PhD, PT
CONTACT
617-643-9237
tkimberley@mgh.harvard.edu

Principal Investigator

Teresa J Kimberley, PhD,PT
PRINCIPAL_INVESTIGATOR
MGH Institute of Health Professions

Study Locations (Sites)

Teresa J Kimberley
Boston, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: MGH Institute of Health Professions

  • Teresa J Kimberley, PhD,PT, PRINCIPAL_INVESTIGATOR, MGH Institute of Health Professions

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-06-10
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • transcranial magnetic stimulation
  • randomized control trial
  • rTMS

Additional Relevant MeSH Terms

  • Laryngeal Dystonia
  • Focal Dystonia