20 Participants NeededMy employer runs this trial

Vibrotactile Stimulation for Spasmodic Dysphonia

(Neuro-VTS-LD Trial)

JK
YT
Overseen ByYu-ting Tseng, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how vibrotactile stimulation (VTS), a non-invasive treatment using gentle vibrations, might help people with laryngeal dystonia, a condition causing voice and speech problems due to muscle spasms. Researchers aim to understand how VTS improves voice quality, eases speaking, and what changes occur in the brain during treatment. Participants with laryngeal dystonia, diagnosed by a specialist and not regularly using certain medications, may qualify. Healthy individuals with no speech issues are also needed for comparison. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly take benzodiazepines.

What prior data suggests that this vibrotactile stimulation is safe for laryngeal dystonia patients?

A previous study found that up to 57% of people with laryngeal dystonia noticed better voice quality after using vibrotactile stimulation (VTS). This non-invasive treatment does not involve surgery or cause pain. While it may produce a mild tingling sensation, most people find it comfortable. Research has also shown that VTS can ease speaking and enhance voice quality without significant side effects. This suggests that VTS is a safe option for managing symptoms of spasmodic dysphonia.12345

Why are researchers excited about this trial?

Researchers are excited about vibrotactile stimulation for spasmodic dysphonia because it offers a non-invasive approach that targets the condition differently from traditional treatments. Most current options, like botulinum toxin injections and voice therapy, focus on symptom management by relaxing muscles or retraining vocal techniques. In contrast, vibrotactile stimulation aims to modulate neural pathways involved in voice control through gentle vibrations, potentially offering a novel way to improve vocal function without the need for injections or intensive therapy sessions. This innovative method could lead to more accessible and less invasive treatment options for patients.

What evidence suggests that vibrotactile stimulation is effective for laryngeal dystonia?

Research has shown that gentle vibrations on the throat, known as vibrotactile stimulation (VTS), can improve voice quality and ease speaking for people with laryngeal dystonia, also called spasmodic dysphonia. One study found that up to 57% of participants experienced significant voice improvements lasting from a few minutes to several days. Another study reported that 64% of participants noticed a clear improvement in voice quality. This trial will compare the effects of VTS on individuals with laryngeal dystonia to healthy controls. The treatment works by applying gentle vibrations to the throat, which seems to help control the muscle spasms causing speech problems. Although scientists continue to study its exact mechanism, VTS is appealing because it is non-invasive, requiring no surgery or other intrusive procedures.12356

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with laryngeal dystonia (spasmodic dysphonia) by a voice disorder specialist. Participants must have their diagnosis confirmed by the study team.

Inclusion Criteria

LD
* Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive vibro-tactile stimulation (VTS) in a controlled laboratory setting for about 20 minutes, with MRI scans before and after the VTS

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in brain resting-state networks and voice parameters after VTS

4 hours

What Are the Treatments Tested in This Trial?

Interventions

  • Vibrotactile Stimulation

Trial Overview

The study tests non-invasive vibrotactile stimulation (VTS) applied to the throat area in people with laryngeal dystonia, and uses MRI scans to see how this affects brain activity and speech symptoms.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Healthy ControlsActive Control1 Intervention
Group II: Laryngeal Dystonia PatientsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Effects of an 11-week vibro-tactile stimulation treatment on ...

We found no conclusive evidence that possible effects of VTS built up longitudinally over the time course of weeks or months as participants did ...

Usability and Feasibility of In-home Vibro-Tactile ...

Results. During weeks 1–4, VTS reduced mean PSE within a session by 13.5% (range: −9% to 44%) with 63% ...

Vibro-tactile stimulation as a non-invasive neuromodulation ...

Results show than VTS can 1) induce head righting and reduce pain in cervical dystonia, 2) improve voice quality and reduce speech effort in ...

Laryngeal Vibration as a Treatment for the Voice Disorder ...

The main findings were that up to 57% of participants showed a meaningful improvement in an objective voice measure (Cepstral Peak Power) or a reduction in ...

Laryngeal Vibration for Spasmodic Dysphonia

The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation.

Neuromodulation for Laryngeal Dystonia: A Systematic ...

All included studies reported various degrees of improvement in patients' voice symptoms with the neuromodulation therapy used. ... No significant ...