CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled / 40 target
Drug / intervention
Vibro-tactile stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06111027
NCT06111027Phase 1CompletedOn Track (1.3/mo)Completion was 20mo ago

Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia

University of Minnesota·interventional·Posted Nov 1, 2023·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating Vibro-tactile stimulation for Spasmodic Dysphonia and Laryngeal Dystonia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The general aim of the study was to provide evidence for the usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (laryngeal dystonia). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
202420252026
First PostedNov 1, 2023
Enrollment StartNov 21, 2023
Primary CompletionOct 28, 2024
Study CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.7 years ago

Arms & Interventions

Interventionexperimental

Laryngeal vibro-tactile stimulation

Device: Vibro-tactile stimulation

Interventions

Vibro-tactile stimulationdevice

Participants received vibro-tactile stimulation (VTS) as a non-invasive treatment option. Stimulators were a pair of light-weight encapsulated cylindrical vibrators applied to both sides of the larynx (voice box). The vibration frequency for VTS was set be to 100Hz. During VTS, participants feel a mild tingling or vibrating sensation at their larynx. They applied VTS at home over a period of 8 weeks with a daily dosage of 20 minutes. During weeks 1-4, the weekly dosage of VTS was gradually increased (week 1: 3 days/wk; week 2: 4 days/wk; week 3: 5 days/wk; week 4: 6 days/wk). During weeks 5-8, participants applied VTS on self-selected days as needed, not exceeding 6 times a week.