Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia (Neuro-VTS-LD)

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).

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Dystonia
• Intervention / Treatment: Device: Vibrotactile Stimulation (VTS)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jürgen Konczak, PhD, Dr. rer. nat. habil.; Phone Number: 612-624-4370; Email: jkonczak@umn.edu
• Study Contact Backup: Name: Yu-ting Tseng, PhD; Phone Number: 612-625-3313; Email: tseng023@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Controls	Device: Vibrotactile Stimulation (VTS); Applied to the laryngeal area using a non-invasive vibrating device.
Active Comparator: Laryngeal Dystonia Patients	Device: Vibrotactile Stimulation (VTS); Applied to the laryngeal area using a non-invasive vibrating device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hour 2.5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Hour 0.5

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysphonia
• Other Study ID Numbers: STUDY00026536; 2-2026 (Other Grant/Funding Number: Dysphonia International)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No