Laryngeal DystoniaNeuro-VTS-LDNCT07443891
Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
A study testing Vibrotactile Stimulation (VTS) in people with Laryngeal Dystonia, run by University of Minnesota at 1 site in United States.
Trial summary
Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal muscles, causing involuntary spasms that impair speech production. Recent research demonstrated that non-invasive vibrotactile stimulation (VTS) of the laryngeal area can provide acute symptom relief in up to 57% of patients, with improvements in voice… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Dystonia
- What is being tested?
- Vibrotactile Stimulation (VTS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
LD Inclusion Criteria:
- Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.
LD Exclusion Criteria:
- Regular intake of benzodiazepines
- Cognitive impairment: score < 27 on Mini-mental state examination; score > 19 on Beck depression inventory
- 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
- Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Pregnant females (if questionable doubt, self-test with over-the-counter pregnancy kit).
- Subjects that exhibit noticeable anxiety and/or claustrophobia.
- Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- Subjects who have known conditions which can lead to emergency medical care.
- Subjects who have been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, or cardiovascular disease, had a brain tumor or stroke, started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
- Subjects who have gotten a non-removable piercing or permanent eyeliner.
- Subjects who have had a head injury that caused the loss of consciousness for more than 30 minutes or have amnesia for more than 24 hours.
- Anyone with a history of head trauma that may have caused Traumatic Brain Injury (TBI), or some type of metal in the body, either from a medical procedure or an injury.
- Any subject with a professional or academic link to one of the PIs.
- We will not enroll vulnerable populations (i.e., fetuses, neonates, pregnant women, children under the age of 18 years, or prisoners).
Healthy Controls Inclusion Criteria:
- Healthy adults, aged 18-75 years with no known neurological or orthopedic deficits that may affect speech motor functions.
Healthy Controls Exclusion Criteria:
- No history of impairments affecting speech or voice function
- Voice Handicap Index-10 (VHI-10) score above normative cut-off values
- Regular intake of benzodiazepines.
- Cognitive impairment: score < 27 on Mini-mental state examination; score > 19 on Beck depression inventory.
- Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Pregnant females (if questionable doubt, self-test with over-the-counter pregnancy kit).
- Subjects that exhibit noticeable anxiety and/or claustrophobia.
- Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- Subjects who have known conditions which can lead to emergency medical care.
- Subjects who have been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, or cardiovascular disease, had a brain tumor or stroke, started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
- Subjects who have gotten a non-removable piercing or permanent eyeliner.
- Subjects who have had a head injury that caused the loss of consciousness for more than 30 minutes or have amnesia for more than 24 hours.
- Anyone with a history of head trauma that may have caused Traumatic Brain Injury (TBI), or some type of metal in the body, either from a medical procedure or an injury.
- Any subject with a professional or academic link to one of the PIs.
- We will not enroll vulnerable populations (i.e., fetuses, neonates, pregnant women, children under the age of 18 years, or prisoners).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Functional Neural Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal muscles, causing involuntary spasms that impair speech production. Recent research demonstrated that non-invasive vibrotactile stimulation (VTS) of the laryngeal area can provide acute symptom relief in up to 57% of patients, with improvements in voice quality and reductions in perceived speech effort lasting from minutes to several days. However, the neural mechanisms underlying this therapeutic effect and the factors determining individual treatment response remain incompletely understood. The objective is to evaluate the acute effects of VTS on voice and speech parameters in participants with LD while characterizing associated changes in brain resting-state networks using magnetic resonance imaging (MRI).
Read the detailed description
To identify the brain networks involved in laryngeal dystonia and any associated changes to this network due to vibro-tactile stimulation (VTS), participants will receive VTS in a controlled laboratory setting for about 20 minutes. They will receive two MRI brain scans, one prior and one after the application of VTS. The scans will take place at the University of Minnesota Center for Magnetic Resonance Research. The total time of the testing procedure that includes receiving VTS and both MRI scans will be approximately 4 hours. This study requires participants to travel Minneapolis.
- Conditions
- Laryngeal Dystonia
- Being tested
- Vibrotactile Stimulation (VTS)
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile Stimulation (VTS)Device
Applied to the laryngeal area using a non-invasive vibrating device.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Dystonia Patients | Active comparator | Not described Receives: Device: Vibrotactile Stimulation (VTS) |
| Healthy Controls | Active comparator | Not described Receives: Device: Vibrotactile Stimulation (VTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Resting-State Functional Connectivity due to VTS
Resting state functional connectivity (rs-fMRI) refers to the brain's activity when a person is not engaged in any specific task. It measures spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal, which indicates brain activity. The rs-fMRI will be obtained twice before and after receiving VTS and the change in rs-fMRI will be obtained.
Measured: Hour 2.5
Secondary outcomes (4)
Cepstral Peak Prominence Smoothed
Cepstral Peak Prominence Smoothed (CPPs) is a quantitative acoustic measure used to assess voice quality. It is measured in decibel (dB) and will be derived from voice recordings of the participant. An increase in dB is associated with a louder and clearer voice in people with laryngeal dystonia.
Measured: Hour 0.5
Changes in Perceived Speech Effort
Perceived speech effort (PSE) will be rated by each participant on a scale of 0-10 (10 indicates maximum vocal effort). Participants will assess their PSE before and after VTS treatment. A reduction in PSE indicates a reduced effort to speak.
Measured: Hour 0.5
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score
The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) inventory (scale of 0-100 with 100 indicating severe dysphonia; score between 30-65 = moderate symptoms, 65-100 = severe symptoms) will be obtained based on the audio recordings from each participant. A speech-language pathologist will rate the audio recordings and derive the CAPE-V for each participant before and after VTS treatment.
Measured: Hour 0.5
Voice Handicap Index
The Voice Handicap Index (VHI) is a self-rated 30-item inventory to indicate the impact of experienced voice problems or a voice disorder (score range: 0-120, score between 0-30 = mild severity; 31-60 = moderate severity; 61-120 = severe severity).
Measured: Hour 0.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start14 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DystoniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443891
- Sponsor's protocol ID
- STUDY00026536
- Other IDs
- 2-2026
- Acronym
- Neuro-VTS-LD
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neural Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
- ClinicalTrials.gov ID
- NCT07443891
- Acronym / sponsor ID
- Neuro-VTS-LD / STUDY00026536
- Conditions
- Laryngeal Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal muscles, causing involuntary spasms that impair speech production. Recent research demonstrated that non-invasive vibrotactile stimulation (VTS) of the laryngeal area can provide acute symptom relief in up to 57% of patients, with improvements in voice quality and reductions in perceived speech effort lasting from minutes to several days. However, the neural mechanisms underlying this therapeutic effect and the factors determining individual treatment response remain incompletely understood. The objective is to evaluate the acute effects of VTS on voice and speech parameters in participants with LD while characterizing associated changes in brain resting-state networks using magnetic resonance imaging (MRI).
Detailed description
To identify the brain networks involved in laryngeal dystonia and any associated changes to this network due to vibro-tactile stimulation (VTS), participants will receive VTS in a controlled laboratory setting for about 20 minutes. They will receive two MRI brain scans, one prior and one after the application of VTS. The scans will take place at the University of Minnesota Center for Magnetic Resonance Research. The total time of the testing procedure that includes receiving VTS and both MRI scans will be approximately 4 hours. This study requires participants to travel Minneapolis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Dystonia Patients | Active comparator | Device: Vibrotactile Stimulation (VTS) |
| Healthy Controls | Active comparator | Device: Vibrotactile Stimulation (VTS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Vibrotactile Stimulation (VTS)Applied to the laryngeal area using a non-invasive vibrating device. | Device | Healthy Controls, Laryngeal Dystonia Patients |
Primary outcome
Change in Brain Resting-State Functional Connectivity due to VTS
Time frame: Hour 2.5
Resting state functional connectivity (rs-fMRI) refers to the brain's activity when a person is not engaged in any specific task. It measures spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal, which indicates brain activity. The rs-fMRI will be obtained twice before and after receiving VTS and the change in rs-fMRI will be obtained.
4 secondary outcomes
Cepstral Peak Prominence Smoothed
Time frame: Hour 0.5
Changes in Perceived Speech Effort
Time frame: Hour 0.5
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score
Time frame: Hour 0.5
Voice Handicap Index
Time frame: Hour 0.5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Stimulation (VTS) in people with 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?
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: looking for participants now, as of the sponsor's last update on 19 Mar 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Konczak, PhD, Dr. rer. nat. habil. (612-624-4370, jkonczak@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Resting-State Functional Connectivity due to VTS (time frame: Hour 2.5). 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 19 Mar 2026.