NCT05095740 Effects of Neuromodulation in Laryngeal Dystonia
| NCT ID | NCT05095740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MGH Institute of Health Professions |
| Condition | Laryngeal Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-06-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2021-06-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Teresa J Kimberley, PhD,PT
PRINCIPAL INVESTIGATOR
MGH Institute of Health Professions
Frequently Asked Questions
Who can join the NCT05095740 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Laryngeal Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05095740 currently recruiting?
Yes, NCT05095740 is actively recruiting participants. Contact the research team at brainrecoverylab@mghihp.edu for enrollment information.
Where is the NCT05095740 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05095740 clinical trial?
NCT05095740 is sponsored by MGH Institute of Health Professions. The principal investigator is Teresa J Kimberley, PhD,PT at MGH Institute of Health Professions. The trial plans to enroll 25 participants.