NCT07443891 Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
| NCT ID | NCT07443891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Laryngeal Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-01-14 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Laryngeal Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443891 currently recruiting?
Yes, NCT07443891 is actively recruiting participants. Contact the research team at jkonczak@umn.edu for enrollment information.
Where is the NCT07443891 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07443891 clinical trial?
NCT07443891 is sponsored by University of Minnesota. The trial plans to enroll 20 participants.