Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia

NCT07443891 | Recruiting FDA Device

• 2 other identifiers: STUDY000265362-2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Laryngeal Dystonia

Outcome Measures

Primary Outcomes (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.

  Hour 2.5

Secondary Outcomes (4)

• Cepstral Peak Prominence Smoothed

  Hour 0.5

• Changes in Perceived Speech Effort

  Hour 0.5

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

  Hour 0.5

• Voice Handicap Index

  Hour 0.5

Study Arms (2)

Laryngeal Dystonia Patients

ACTIVE COMPARATOR

Device: Vibrotactile Stimulation (VTS)

Healthy Controls

ACTIVE COMPARATOR

Device: Vibrotactile Stimulation (VTS)

Interventions

Vibrotactile Stimulation (VTS) DEVICE

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

Healthy Controls; Laryngeal Dystonia Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 2, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)