Vibro-tactile Stimulation for Spasmodic Dysphonia

Overseen By Jürgen Konczak, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must not be taking: Benzodiazepines

Disqualifiers: Cognitive impairment, Neurological impairments, Non-English speakers, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if vibro-tactile stimulation (VTS), a non-invasive therapy, can improve speech in individuals with spasmodic dysphonia, a voice disorder causing involuntary muscle spasms in the larynx. Participants will receive either high or low doses of VTS, with sessions occurring during speech or as continuous stimulation. Those who have experienced spasmodic dysphonia for at least six months and do not regularly take benzodiazepines might be suitable candidates. The goal is to assess whether VTS can help manage symptoms of this condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in managing their condition.

Will I have to stop taking my current medications?

The trial excludes people who regularly take benzodiazepines, so you would need to stop taking them to participate. For other medications, the protocol does not specify if you need to stop taking them.

What prior data suggests that vibro-tactile stimulation is safe for treating spasmodic dysphonia?

Research shows that vibro-tactile stimulation (VTS) is generally safe for people. It is a non-invasive method, meaning it doesn't involve surgery or entering the body. In past studies, patients with spasmodic dysphonia, a voice disorder, have tolerated VTS well.

One study found that using VTS at home was practical and safe for daily use. Another study with 130 patients examined different therapies, including VTS, for treating laryngeal dystonia and reported no major side effects.

Overall, evidence suggests that VTS is a safe option for people with this voice disorder. However, as with any treatment, discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about vibro-tactile stimulation (VTS) for treating spasmodic dysphonia because it offers a non-invasive approach that could provide relief without the need for injections or surgeries, which are the current standard treatments. Unlike botulinum toxin injections that temporarily paralyze muscles or surgical interventions that alter nerve function, VTS uses gentle vibrations to potentially stabilize vocal cord function during speech. This technique is being tested in different dosages and modes of application, such as high or low doses and either continuous or speech-activated stimulation, to determine the most effective way to improve voice quality. This offers a promising alternative for those seeking less invasive options with potentially fewer side effects.

What evidence suggests that vibro-tactile stimulation is effective for spasmodic dysphonia?

Research has shown that vibro-tactile stimulation (VTS) can improve the voice of people with laryngeal dystonia, also known as spasmodic dysphonia. In an 11-week study, participants experienced consistent improvements in voice quality with regular VTS use. Another study found that even a single 30-minute VTS session noticeably improved voice quality. Participants in this trial will receive different dosages and types of VTS, such as high or low dose and speech-activated or continuous VTS. Participants have reported that speaking feels easier and their voice sounds better, suggesting VTS as an effective and non-invasive treatment option. Patients also respond positively to the treatment, making it a promising way to manage this condition. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of adductor or abductor spasmodic dysphonia (a voice disorder) for at least 6 months. It's not suitable for those with cognitive issues, regular benzodiazepine users, pregnant individuals, non-English speakers, or people with certain neurological conditions affecting speech.

Inclusion Criteria

I have been diagnosed with laryngeal dystonia for at least 6 months.

Exclusion Criteria

Pregnant people.

I regularly take benzodiazepines.

I have a condition affecting my ability to speak due to muscle or nerve issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vibro-tactile stimulation (VTS) with varying doses and activation methods

24 months

7 visits/week for high dose, 5 visits/week for low dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibro-tactile stimulation (VTS)

Trial Overview The study tests whether vibro-tactile stimulation (VTS), a non-invasive treatment that uses vibrations on the throat area, can improve speech in patients suffering from laryngeal dystonia or spasmodic dysphonia.

How Is the Trial Designed?

Group I: Low dose / speech activated VTS Experimental Treatment 1 Intervention

Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech

Group II: Low dose / continuous VTS Experimental Treatment 1 Intervention

Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Group III: High dose / speech activated VTS Experimental Treatment 1 Intervention

High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech

Group IV: High dose / continuous VTS Experimental Treatment 1 Intervention

High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Patients with adductor and abductor spasmodic dysphonia (SD) show distinct brain activation patterns, with increased activity in the primary sensorimotor cortex and decreased activity in the basal ganglia, thalamus, and cerebellum during voice tasks, indicating potential neural mechanisms underlying the disorder.

The primary somatosensory cortex appears to play a significant role in the pathophysiology of SD, as its activation correlates with symptom severity, suggesting it could be a target for future therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal activation of the primary somatosensory cortex in spasmodic dysphonia: an fMRI study. Simonyan, K., Ludlow, CL.[2021]

The study involved 14 patients with adductor-type spasmodic dysphonia (ADSD) and 15 control subjects, using functional MRI to assess central tactile processing and resting-state connectivity before and during the effects of botulinum neurotoxin type A (BoNT-A).

Findings revealed that ADSD patients exhibited abnormal tactile processing and increased connectivity in certain brain regions, but BoNT-A treatment did not significantly change these activation patterns, suggesting that central sensory processing abnormalities are a key feature of ADSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered sensory system activity and connectivity patterns in adductor spasmodic dysphonia. Mantel, T., Dresel, C., Welte, M., et al.[2021]

In a study involving 5 subjects with spasmodic dysphonia, electrical stimulation of the thyroarytenoid muscle led to significant improvements in voice evaluations for 4 out of the 5 participants, suggesting the treatment's efficacy.

The study demonstrated the feasibility of implanting an electrical stimulation device in the thyroarytenoid muscle, indicating potential for a new treatment approach for spasmodic dysphonia through neuromodulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of spasmodic dysphonia with a neuromodulating electrical implant. Pitman, MJ.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11169659/

Effects of an 11-week vibro-tactile stimulation treatment on ... This study provides the first systematic empirical evidence that the prolonged use of laryngeal VTS can induce repeatable acute improvements in voice quality.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06111027

Usability of Vibro-tactile Stimulation to Treat Spasmodic ... The general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199725003297

Usability and Feasibility of In-home Vibro-Tactile ... VTS can reduce speech effort and improve voice quality in people with LD with repeatable effects and high patient acceptance. Results ...

4. hsc.umn.edu hsc.umn.edu/vibro-tactile-stimulation-topic/laryngeal-vibration-treatment-voice-disorder

Laryngeal Vibration as a Treatment for the Voice Disorder ... A one-time 30-minute application of VTS over the laryngeal area can result in measurable improvements in the voice quality of people with LD.

5. nature.com nature.com/articles/s41598-019-54396-4

Laryngeal vibration as a non-invasive neuromodulation ... This pilot-feasibility study explored whether laryngeal vibro-tactile stimulation can provide benefits for patients with spasmodic dysphonia by ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199725001110

Neuromodulation for Laryngeal Dystonia: A Systematic ... In total, 130 LD patients were identified with the following neuromodulation therapies being evaluated for their use in LD: vibro-tactile ...