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

Trial Summary

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 data supports the effectiveness of the treatment Vibro-tactile stimulation (VTS) for spasmodic dysphonia?

A study found that Vibro-tactile stimulation (VTS) improved voice quality in 69% of participants with spasmodic dysphonia by reducing voice breaks and enhancing speech quality. These improvements lasted for 20 minutes after the treatment, suggesting that VTS can temporarily help with voice issues in this condition. ^{1 2 3 4 5}

Is vibro-tactile stimulation (VTS) safe for humans?

The study on laryngeal VTS for spasmodic dysphonia did not report any safety concerns, but more research is needed to understand its long-term effects and optimal dosage. ^{1 3 6 7 8}

How does the treatment Vibro-tactile Stimulation (VTS) for spasmodic dysphonia differ from other treatments?

Vibro-tactile Stimulation (VTS) is unique because it uses vibrations to alter brain activity related to speech control, offering a non-invasive way to improve voice quality in spasmodic dysphonia. Unlike other treatments like Botulinum toxin injections, which temporarily paralyze muscles, VTS modulates brain activity to reduce voice breaks and improve speech quality. ^{1 2 3 9 10}

What is the purpose of this trial?

The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Altered sensory system activity and connectivity patterns in adductor spasmodic dysphonia. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Abnormal activation of the primary somatosensory cortex in spasmodic dysphonia: an fMRI study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Laryngeal long latency response conditioning in abductor spasmodic dysphonia. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the implantable recurrent laryngeal nerve stimulator. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Abnormalities in long latency responses to superior laryngeal nerve stimulation in adductor spasmodic dysphonia. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Implantation of a recurrent laryngeal nerve stimulator for the treatment of spastic dysphonia. [2017]

9. Germany pubmed.ncbi.nlm.nih.gov

Tridimensional assessment of adductor spasmodic dysphonia pre- and post-treatment with Botulinum toxin. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Multichannel electromyographic observations in spasmodic dysphonia patients and normal control subjects. [2017]