How gentle vibration to the throat affects brain activity in people with laryngeal dystonia

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

This study will test whether a short session of noninvasive vibro-tactile stimulation to the larynx can improve voice symptoms and alter brain network activity in adults with laryngeal dystonia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Minnesota (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT07443891 on ClinicalTrials.gov

What this trial studies

Participants with confirmed laryngeal dystonia will receive about 20 minutes of noninvasive vibro-tactile stimulation to the laryngeal area. Each participant will undergo two resting-state MRI scans—one before and one after the stimulation—to identify changes in brain networks. Voice and speech parameters will be recorded acutely to link symptom changes with imaging findings. The full on-site testing session, including MRI and stimulation, takes roughly four hours and requires travel to Minneapolis.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of laryngeal dystonia who can undergo MRI, do not regularly take benzodiazepines, have no disqualifying neurological or musculoskeletal disorders affecting speech, and can travel to the University of Minnesota are ideal candidates.

Not a fit: People with other neurological or musculoskeletal conditions affecting speech, those with MRI-incompatible implants, regular benzodiazepine use, or significant cognitive impairment are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could point to a noninvasive therapy that temporarily improves voice quality and reduces speaking effort for some people with laryngeal dystonia.

How similar studies have performed: Prior small studies have reported acute voice improvements with laryngeal vibro-tactile stimulation in up to about 57% of patients, but the underlying brain mechanisms remain incompletely characterized.

Eligibility criteria

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).

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)

Study contacts

• Study coordinator: Jürgen Konczak, PhD, Dr. rer. nat. habil.

Conditions: Laryngeal Dystonia