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NCT05095740 · ClinicalTrials.gov registry record · NA
Effects of Neuromodulation in Laryngeal Dystonia
A NA study of Laryngeal Dystonia and Focal Dystonia, sponsored by MGH Institute of Health Professions.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05095740 is a NA study of Laryngeal Dystonia and Focal Dystonia that is actively recruiting participants, run by MGH Institute of Health Professions. The registered enrollment target is 25 participants, below the 107-participant average among 9 other Laryngeal Dystonia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05095740, a NA study of Laryngeal Dystonia and Focal Dystonia, is actively recruiting participants, sponsored by MGH Institute of Health Professions.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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 sh
Conditions Studied
Interventions
- DEVICE sham rTMS
- DEVICE repetitive transcranial magnetic stimulation (rTMS)
Study Locations (1)
Massachusetts
- Teresa J Kimberley - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05095740
The ClinicalTrials.gov registry entry for NCT05095740 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 9 other Laryngeal Dystonia trials with a reported enrollment target (77% lower). The listed sponsor is MGH Institute of Health Professions, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Laryngeal Dystonia appearing as the primary indexed condition, and to 2 interventions - of which sham rTMS is the first listed.
NCT05095740 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05095740 about?
NCT05095740 is a clinical study titled "Effects of Neuromodulation in Laryngeal Dystonia". 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 p...
What is the current status of trial NCT05095740?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2021-06-10. Estimated completion is 2026-12-31.
What conditions does trial NCT05095740 study?
This clinical trial studies the following conditions: Laryngeal Dystonia, Focal Dystonia.
What interventions are being tested in trial NCT05095740?
The interventions under investigation include: sham rTMS (DEVICE), repetitive transcranial magnetic stimulation (rTMS) (DEVICE).
Who is sponsoring clinical trial NCT05095740?
This trial is sponsored by MGH Institute of Health Professions, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05095740 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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