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Neuromodulation

rTMS for Laryngeal Dystonia

N/A
Recruiting
Led By Teresa J Kimberley, PhD,PT
Research Sponsored by MGH Institute of Health Professions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range is 21-85 years
Diagnosis of Laryngeal Dystonia (LD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline), day 5 (post intervention), and day 12 (follow up) timepoints for both arms of the study.
Awards & highlights

Study Summary

This trial will investigate the effect of a non-invasive neuromodulation technique, repetitive transcranial magnetic stimulation (rTMS), on people with laryngeal dystonia (LD). It is hypothesized that following low frequency (inhibitory) rTMS to the laryngeal motor brain area, there will be a decrease in overactivation of the TA muscle.

Who is the study for?
This trial is for adults aged 21-85 with Laryngeal Dystonia, who can consent and are at their worst symptom severity even if they're receiving Botox injections. It's not for those with other dystonias, laryngeal cancer, certain neurologic conditions or medications, contraindications to rTMS, essential tremor, recent seizures or past vocal fold surgeries.Check my eligibility
What is being tested?
The study tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation method on people with Laryngeal Dystonia. Participants will be randomly assigned to receive either real rTMS or sham (fake) treatment to compare effects on muscle control in the voice box.See study design
What are the potential side effects?
While rTMS is generally considered safe, potential side effects include discomfort at the stimulation site, headache, lightheadedness, tingling sensations or spasms of facial muscles. Rarely it could cause seizures but only in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 85 years old.
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I have been diagnosed with Laryngeal Dystonia.
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My symptoms are at their worst despite getting botulinum toxin injections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline), day 5 (post intervention), and day 12 (follow up) timepoints for both arms of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), day 5 (post intervention), and day 12 (follow up) timepoints for both arms of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cortical Excitability (intrahemispheric inhibition)
Change in Objective Assessment of Phonatory Function
Secondary outcome measures
Secondary Objective assessment of phonatory function
Self Ratings of Voice Effort
Subjective Assessment of Phonatory Function
Other outcome measures
Forced choice paired assessment of phonatory function

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: repetitive transcranial magnetic stimulation (rTMS)Active Control1 Intervention
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.
Group II: Sham rTMSPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,256 Total Patients Enrolled
3 Trials studying Spasmodic Dysphonia
235 Patients Enrolled for Spasmodic Dysphonia
MGH Institute of Health ProfessionsLead Sponsor
15 Previous Clinical Trials
3,595 Total Patients Enrolled
Teresa J Kimberley, PhD,PTPrincipal InvestigatorMGH Institute of Health Professions

Media Library

Repetitive Transcranial Magnetic Stimulation (rTMS) (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05095740 — N/A
Spasmodic Dysphonia Research Study Groups: repetitive transcranial magnetic stimulation (rTMS), Sham rTMS
Spasmodic Dysphonia Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT05095740 — N/A
Repetitive Transcranial Magnetic Stimulation (rTMS) (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095740 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific experiment permit individuals above 30 years of age to participate?

"This clinical trial is seeking applicants aged 21 to 85. There are 4 trials specifically for those younger than 18, and 47 studies available for people over the age of 65."

Answered by AI

Is this research endeavor actively seeking participants?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which initially launched on June 10th 2021, is actively recruiting participants. 60 test subjects are required to join the trial at a single site."

Answered by AI

Does my profile meet the requirements to join this clinical trial?

"For this dysphonia investigation, 60 individuals ranging from 21 to 85 years old are being recruited. Furthermore, they need to fulfill the following criteria: suffering from chronically extreme symptoms of their ailment even if receiving treatment with botulinum toxin injections and have filled out a consent form."

Answered by AI

What is the upper limit of individuals participating in this clinical experiment?

"Affirmative. Information hosted on clinicaltrials.gov suggest that this research venture, originally posted on June 10th 2021 is still actively looking for participants. 60 individuals are being sought out from one medical facility."

Answered by AI
Recent research and studies
~17 spots leftby May 2025