Adductor Spasmodic DysphoniaPhase 2NCT05467228
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
A Phase 2 study testing vibro-tactile stimulation (VTS) in people with Adductor Spasmodic Dysphonia and Abductor Spastic Dysphonia, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia
- What is being tested?
- vibro-tactile stimulation (VTS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
Who cannot join
- Regular intake of benzodiazepines
- Cognitive impairment: score < 27 on the Mini-mental State Examination (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 investigational.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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).
- Being tested
- vibro-tactile stimulation (VTS)
- Keywords
- Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia, Vibtro-tactile stimulation
- 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 stimulation (VTS)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Low dose / continuous VTS | Experimental | Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech Receives: Device: vibro-tactile stimulation (VTS) |
| Low dose / speech activated VTS | Experimental | Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech Receives: Device: vibro-tactile stimulation (VTS) |
| High dose / continuous VTS | Experimental | High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech Receives: Device: vibro-tactile stimulation (VTS) |
| High dose / speech activated VTS | Experimental | High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech Receives: Device: vibro-tactile stimulation (VTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
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)
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startAug 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Why it stopped: Did not get funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467228
- Sponsor's protocol ID
- KIN-2022-30628
- Status last verified
- May 2025
- First submitted
- 12 Jul 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT05467228
- Acronym / sponsor ID
- KIN-2022-30628
- Keywords
- Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia, Vibtro-tactile stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not get funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose / continuous VTS | Experimental | Device: vibro-tactile stimulation (VTS)Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech |
| Low dose / speech activated VTS | Experimental | Device: vibro-tactile stimulation (VTS)Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech |
| High dose / continuous VTS | Experimental | Device: vibro-tactile stimulation (VTS)High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech |
| High dose / speech activated VTS | Experimental | Device: vibro-tactile stimulation (VTS)High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
Key exclusion criteria (5 listed)
- Regular intake of benzodiazepines
- Cognitive impairment: score < 27 on the Mini-mental State Examination (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 investigational.
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 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 | Device | High dose / continuous VTS, High dose / speech activated VTS, Low dose / continuous VTS, Low dose / speech activated VTS |
Primary outcome
Change in perceived speech effort (PSE)
Time frame: 24 months
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
Change in smoothed cepstral peak prominence (CPPS)
Time frame: 24 months
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
Change in speech quality vector (SQV) (%)
Time frame: 24 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Related trials for Adductor Spasmodic Dysphonia
RecruitingObservational study
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vibro-tactile stimulation (VTS) in people with Adductor Spasmodic Dysphonia and Abductor Spastic Dysphonia, 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 5 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: withdrawn, as of the sponsor's last update on 16 May 2025. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in perceived speech effort (PSE) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.