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NCT06111027 · ClinicalTrials.gov registry record · Phase 1

Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

A Phase 1 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT06111027: Completed Phase 1 study, sponsored by University of Minnesota.

NCT06111027 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06111027, a Phase 1 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study 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.

Primary Outcome

Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness. Ratings were collected immediately before and after each vibro-tactile stimulation session. The PSE value reported here reflects the group mean at week 4.

Interventions

  • DEVICE Vibro-tactile stimulation

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-11-21
Est. Completion 2024-10-31
Phase Phase 1
University of Minnesota

966 total trials

What the finished NCT06111027 record still lists

NCT06111027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 1 intervention - of which Vibro-tactile stimulation is the first listed.

NCT06111027 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06111027 about?

NCT06111027 is a clinical study titled "Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia". 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 devel...

What is the current status of trial NCT06111027?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-11-21. Estimated completion is 2024-10-31.

What interventions are being tested in trial NCT06111027?

The interventions under investigation include: Vibro-tactile stimulation (DEVICE).

Who is sponsoring clinical trial NCT06111027?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06111027's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06111027, the US trial registry maintained by the National Library of Medicine. NCT06111027 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.