What side effects are associated with this type of intervention?

Common treatments for Spasmodic Dysphonia include Botulinum Toxin (Botox) injections and repetitive transcranial magnetic stimulation (rTMS). Botox injections, which alleviate muscle spasms in the vocal folds, can cause side effects such as breathiness, swallowing difficulties, and a temporary weak voice. rTMS, a non-invasive neuromodulation technique, has shown potential in improving voice quality by decreasing cortical excitability and inhibition of laryngeal musculature. Known side effects of rTMS are generally mild and may include headaches, scalp discomfort, and tingling sensations. Both treatments aim to improve voice quality but come with their respective side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

For the treatment of Spasmodic Dysphonia, Botulinum Toxin (Botox) injections have been FDA-approved and are commonly used to alleviate muscle spasms in the vocal folds. This treatment is well-established and provides temporary relief by reducing muscle overactivity. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive neuromodulation technique aimed at decreasing cortical excitability and inhibition of laryngeal musculature, is currently being studied but has not yet received FDA approval specifically for Spasmodic Dysphonia.

What other types of research exist?

Promising, novel alternatives to rTMS for Spasmodic Dysphonia include Transcranial Direct Current Stimulation (tDCS), which has shown efficacy in treating aphasia and other neurological conditions, and Vagal Nerve Stimulation (VNS), which has been associated with reduced headache burden in migraine patients. Both methods are non-invasive and have potential applicability to neuromodulation in Spasmodic Dysphonia.

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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)

Must not have

Laryngeal cancer or other neurologic conditions with medications affecting the central nervous system

Other forms of dystonia

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.

Summary

This trial investigates the use of rTMS, a non-invasive procedure using magnetic fields, to help people with laryngeal dystonia. These individuals have voice issues due to muscle spasms, and current treatments are not very effective. rTMS aims to reduce overactivity in brain areas controlling the larynx muscles, potentially improving their voice quality. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive technique used for treating various neurological and psychiatric conditions by changing brain activity.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have laryngeal cancer or a condition affecting my brain or nerves.

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I have a type of dystonia.

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I have been diagnosed with essential tremor.

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I am unable to give consent or participate in the study procedures.

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I cannot have rTMS due to health reasons.

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I have had surgery on my voice box.

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I have a vocal cord condition or paralysis.

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I have had a seizure within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline), day 5 (post intervention), and day 12 (follow up) timepoints for both arms of the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cortical Excitability (intrahemispheric inhibition)

Change in Objective Assessment of Phonatory Function

Secondary study objectives

Secondary Objective assessment of phonatory function

Self Ratings of Voice Effort

Subjective Assessment of Phonatory Function

Other study objectives

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spasmodic Dysphonia (SD) treatments primarily include Botulinum Toxin (Botox) injections and voice therapy. Botox temporarily paralyzes the overactive laryngeal muscles, reducing spasms and improving voice quality. Voice therapy focuses on enhancing vocal techniques to minimize strain. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive neuromodulation technique, targets brain areas controlling the laryngeal muscles to decrease cortical excitability and inhibition, potentially reducing muscle overactivation. These treatments are essential for SD patients as they offer tailored approaches to manage symptoms and improve vocal function.

Neuronavigated high-frequency repetitive transcranial magnetic stimulation for chronic post-stroke dysphagia: A randomized controlled study.