Spasmodic DysphoniaPhase 1/2NCT06111027

Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

A Phase 1/2 study testing Vibro-tactile stimulation in people with Spasmodic Dysphonia and Laryngeal Dystonia, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Spasmodic Dysphonia, Laryngeal Dystonia
What is being tested?: Vibro-tactile stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2023to 31 Oct 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
Diagnosis is made by a voice disorder specialist.

Who cannot join

Regular intake of benzodiazepines
Cognitive impairment: score < 27 on Mini-mental state examination
Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, 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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55414

Other trials in United States

About this study

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

Read the detailed description

Participants with either adductor or abductor-type of spasmodic dysphonia applied VTS at home for a period of 2 months. During the first four weeks they gradually increased their weekly dosage from 3 to 6 days per week. Each application per day lasted 20 minutes.

Conditions: Spasmodic Dysphonia, Laryngeal Dystonia
Being tested: Vibro-tactile stimulation
Keywords: in-home therapy, vibration, vibro-tactile, laryngeal dystonia
Medical subject headings: Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06111027
Study group	Role	What they receive
Intervention	Experimental	Laryngeal vibro-tactile stimulation Receives: Device: Vibro-tactile stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Perceived Speech Effort (PSE) at Week 4
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.
Measured: Week 4
Perceived Speech Effort (PSE) at Week 8
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 8.
Measured: Week 8
Voice Quality Change (VQC) at Week 1
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. VQC at week 1 represents a baseline measure of symptom severity. It was computed as the mean of the first three sessions of VTS of the study.
Measured: Week 1
Voice Quality Change (VQC) at Week 8
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. The score reflects the overall longitudinal change in symptoms experienced after treatment end. VQC at week 8 was computed as the mean of the last three sessions of the study.
Measured: Week 8

Secondary outcomes (2)

Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method
Relative change in PSE (rPSE) was calculated as [(Post - Pre) / Pre] × 100. The between-group difference in mean rPSE comparing VTS received during direct skin contact vs. VTS collar was assessed over the total study period of 8 weeks to understand if the VTS applied directly to the skin was more effective in reducing speech effort than VTS applied via the collar.
Measured: 8 weeks
Adherence Rate (Feasibility)
Number of participants who completed at least 80% of prescribed VTS sessions during the intervention period.
Measured: Week 1-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202331 Oct 2024

First posted1 Nov 2023
Study start21 Nov 2023
Primary completion28 Oct 2024
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Usability study
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06111027
Sponsor's protocol ID: STUDY00019659
Status last verified: Jun 2026
First submitted: 16 Oct 2023
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.
PubMed 38872829
Mahnan A, Xu J, Oh J, Bhaskaran D, Zhang Y, Watson PJ, Konczak J. Laryngeal Vibration to Treat Abductor-Type Laryngeal Dystonia: Effectiveness and Cortical Response. Laryngoscope. 2026 Jan;136(1):368-376. doi: 10.1002/lary.70020. Epub 2025 Aug 8.
PubMed 40776766
Amini S, Elangovan N, Ozkul C, Konczak J. Usability and Feasibility of In-home Vibro-Tactile Stimulation for Treating Voice Symptoms in Laryngeal Dystonia. J Voice. 2025 Aug 23:S0892-1997(25)00329-7. doi: 10.1016/j.jvoice.2025.08.012. Online ahead of print.
PubMed 40850907

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
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Transcranial Magnetic Stimulation in Laryngeal Dystonia
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Not yet recruitingPhase 1
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
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Recruiting
Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
Laryngeal Dystonia

All Spasmodic Dysphonia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
ClinicalTrials.gov ID: NCT06111027
Acronym / sponsor ID: STUDY00019659
Conditions: Spasmodic Dysphonia, Laryngeal Dystonia
Keywords: in-home therapy, vibration, vibro-tactile, laryngeal dystonia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Spasmodic Dysphonia Association
Study start: 21 Nov 2023 (actual)
Primary completion: 28 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 1 Nov 2023 (actual)
Results: Posted 25 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Usability study

Arm	Type	Receives
Intervention	Experimental	Device: Vibro-tactile stimulationLaryngeal vibro-tactile stimulation

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
Diagnosis is made by a voice disorder specialist.

Key exclusion criteria (3 listed)

Regular intake of benzodiazepines
Cognitive impairment: score < 27 on Mini-mental state examination
Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vibro-tactile stimulationParticipants 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.	Device	Intervention

Primary outcome

Perceived Speech Effort (PSE) at Week 4
Time frame: Week 4
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.
Perceived Speech Effort (PSE) at Week 8
Time frame: Week 8
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 8.
Voice Quality Change (VQC) at Week 1
Time frame: Week 1
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. VQC at week 1 represents a baseline measure of symptom severity. It was computed as the mean of the first three sessions of VTS of the study.
Voice Quality Change (VQC) at Week 8
Time frame: Week 8
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. The score reflects the overall longitudinal change in symptoms experienced after treatment end. VQC at week 8 was computed as the mean of the last three sessions of the study.

2 secondary outcomes

Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method
Time frame: 8 weeks
Adherence Rate (Feasibility)
Time frame: Week 1-4

Results and safety

Results posted to the registry on 25 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	40	32

Primary outcome: Perceived Speech Effort (PSE) at Week 4

Time frame: Week 4. Mean (Standard Deviation). Unit: Score on a scale of 1-10

Measure	Intervention n = 32
Value	4.8 (1.3)

Primary outcome: Perceived Speech Effort (PSE) at Week 8

Time frame: Week 8. Mean (Standard Deviation). Unit: Score on a scale

Measure	Intervention n = 32
Value	4.4 (1.5)

Primary outcome: Voice Quality Change (VQC) at Week 1

Time frame: Week 1. Mean (Standard Deviation). Unit: Unitless score on a scale between 1-5

Measure	Intervention n = 32
Value	2.9 (0.6)

Primary outcome: Voice Quality Change (VQC) at Week 8

Time frame: Week 8. Mean (Standard Deviation). Unit: Unitless score on a scale between 1-5

Measure	Intervention n = 32
Value	3.8 (0.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of the intervention through the end of the study period (e.g., after 8 weeks of home-based VTS use).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32

Limitations and caveats (from the sponsor): This single-arm, non-randomized study without a control condition was designed to establish the feasibility and usability of prolonged in-home use of VTS for people with LD (spasmodic dysphonia). Ratings of perceived speech effort and voice quality proved to be useful markers of user experience. The obtained data on treatment effectiveness warrant careful interpretation, because the study did not constitute a randomized controlled clinical trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38872829Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.
Background: PubMed 40776766Mahnan A, Xu J, Oh J, Bhaskaran D, Zhang Y, Watson PJ, Konczak J. Laryngeal Vibration to Treat Abductor-Type Laryngeal Dystonia: Effectiveness and Cortical Response. Laryngoscope. 2026 Jan;136(1):368-376. doi: 10.1002/lary.70020. Epub 2025 Aug 8.
Results publication: PubMed 40850907Amini S, Elangovan N, Ozkul C, Konczak J. Usability and Feasibility of In-home Vibro-Tactile Stimulation for Treating Voice Symptoms in Laryngeal Dystonia. J Voice. 2025 Aug 23:S0892-1997(25)00329-7. doi: 10.1016/j.jvoice.2025.08.012. Online ahead of print.
Human Sensorimotor Control Laboratory - Information on studies using vibro-tactile stimulation to treat focal dystonia of the neck and larynxLink provided by the sponsor.

Related trials for Spasmodic Dysphonia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juergen Konczak, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vibro-tactile stimulation in people with Spasmodic Dysphonia and Laryngeal Dystonia, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Speech Effort (PSE) at Week 4 (time frame: Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111027, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.