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Behavioural Intervention

Vibro-tactile Stimulation for Spasmodic Dysphonia

Phase 2

Waitlist Available

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing whether vibro-tactile stimulation can help improve the speech of people with laryngeal dystonia (a movement disorder that affects the muscles of the larynx).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since VTS is non-invasive and doesn't involve drugs, significant side effects are not expected. However, participants may experience discomfort or mild irritation where the device touches the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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 perceived speech effort (PSE)

Change in smoothed cepstral peak prominence (CPPS)

Change in speech quality vector (SQV) (%)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Low dose / speech activated VTSExperimental Treatment1 Intervention

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

Group II: Low dose / continuous VTSExperimental Treatment1 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 VTSExperimental Treatment1 Intervention

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

Group IV: High dose / continuous VTSExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,378 Previous Clinical Trials

1,588,449 Total Patients Enrolled

Media Library

Vibro-tactile stimulation (VTS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05467228 — Phase 2

Adductor Spasmodic Dysphonia Research Study Groups: High dose / speech activated VTS, Low dose / continuous VTS, Low dose / speech activated VTS, High dose / continuous VTS

Adductor Spasmodic Dysphonia Clinical Trial 2023: Vibro-tactile stimulation (VTS) Highlights & Side Effects. Trial Name: NCT05467228 — Phase 2

Vibro-tactile stimulation (VTS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467228 — Phase 2

Frequently Asked Questions

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

Do you need any more participants for this experiment?

"The clinical trial in question is not actively recruiting patients at this time. However, the study's last update was on October 15th, 2022 and it was originally posted April 1st, 2023. Additionally, there are 122 other trials that are currently looking for participants."

Answered by AI

What is the FDA's position on VTS?

"This medical intervention has not been proven effective, but there is some data indicating that it is safe. Therefore, our team rates the safety of vibro-tactile stimulation (VTS) as a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia

2024. "Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467228.

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