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NCT Number: NCT07443891

Brain 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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vibrotactile Stimulation (VTS)

Device

Applied to the laryngeal area using a non-invasive vibrating device.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cepstral Peak Prominence Smoothed

    Time frame: Hour 0.5

    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.

  2. Changes in Perceived Speech Effort

    Time frame: Hour 0.5

    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.

  3. Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score

    Time frame: Hour 0.5

    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.

  4. Voice Handicap Index

    Time frame: Hour 0.5

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

612-624-4370

Yu-ting Tseng, PhD

CONTACT

[email protected]

612-625-3313

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Functional Neural Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia

Acronym: Neuro-VTS-LD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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