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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Jürgen Konczak, PhD, Dr. rer. nat. habil. contact

612-624-4370

jkonczak@umn.edu

Yu-ting Tseng, PhD contact

612-625-3313

tseng023@umn.edu

United States1 site, 1 recruiting
  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Recruiting

Other trials in United States

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.

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 groups in NCT07443891
Study groupRoleWhat they receive
Laryngeal Dystonia PatientsActive comparatorNot described
Receives: Device: Vibrotactile Stimulation (VTS)
Healthy ControlsActive comparatorNot described
Receives: Device: Vibrotactile Stimulation (VTS)

What is being measured

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

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted2 Mar 2026
  2. Study start14 Jan 2026
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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)
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

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.

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