ClinicalTrials.gg
WithdrawnNCT05467228Updated May 16, 2025

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

A Phase 2 interventional study of vibro-tactile stimulation (VTS) in Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia and Laryngeal Dystonia, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Did not get funded
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.

Enrollment
52nd of 53
0 · median 32
Started
2026
with 5 others
Phase 2
4 of 71
none open now
Registered
54th of 71
by date
Lead sponsor
6 of 71
University of Minnesota

Among the 71 studies in Dysphonia with a site in United States, this one is the 52nd largest by enrollment of the 53 interventional ones, is one of 6 that started in 2026, is one of 4 in phase 2, and was the 54th registered.

By phase

71 studies; the count open now beside each. This study's row is marked.

No phase31 · 12 open
Observational18 · 4 open
Phase 1/25 · 0 open
Phase 45 · 1 open
Phase 14 · 2 open
Phase 2this study4 · 0 open
Phase 2/32 · 0 open
Phase 32 · 1 open

By the year they started

First in 1992; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 71 studies in Dysphonia with a site in United States, or all of them as a file.
02

Study summary

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).

03

Conditions studied

  • Adductor Spasmodic Dysphonia
  • Abductor Spastic Dysphonia
  • Laryngeal Dystonia

Browse trials for

Keywords

  • Adductor Spasmodic Dysphonia
  • Abductor Spastic Dysphonia
  • Laryngeal Dystonia
  • Vibtro-tactile stimulation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older
  • Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.

Exclusion criteria

Exclusion Criteria:

  • Regular intake of benzodiazepines
  • Cognitive impairment: score \< 27 on the (MMSE).
  • Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
  • Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
  • Pregnant people. We will not enroll pregnant people as the device used in this study is .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Low dose / continuous VTS

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

    Device: vibro-tactile stimulation (VTS)

  • Experimental
    Low dose / speech activated VTS

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

    Device: vibro-tactile stimulation (VTS)

  • Experimental
    High dose / continuous VTS

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

    Device: vibro-tactile stimulation (VTS)

  • Experimental
    High dose / speech activated VTS

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

    Device: vibro-tactile stimulation (VTS)

Interventions

  • Devicevibro-tactile stimulation (VTS)

    To apply vibro-tactile stimulation, participants will use a wearable device. It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (\~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage. For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second

06

What researchers measure

Primary outcomes

  1. Change in perceived speech effort (PSE)

    Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)

    Time frame: 24 months

  2. Change in smoothed cepstral peak prominence (CPPS)

    CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)

    Time frame: 24 months

  3. Change in speech quality vector (SQV) (%)

    A derived measure designed to understand if a participant's voice symptom improvement occurs across objective (CPPS) and subjective measures of speech (PSE). It is based on the relative change between two time points

    Time frame: 24 months

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Aug 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2022
First posted
Jul 20, 2022
StartEst.
Aug 2026
Primary completionEst.
Aug 1, 2026
CompletionEst.
Aug 1, 2026
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05467228
Responsible party
Sponsor
First posted
Jul 20, 2022
Start date
Aug 2026 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
May 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion