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New treatment option for Laryngeal Dystonia
Official title Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
ClinicalTrials.gov ID: NCT07443891
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.
You likely can't join if
- Regular intake of benzodiazepines
- Cognitive impairment: 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...
- people with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators...
- people 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).
See the full eligibility criteria
Who can join
- Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.
What rules you out
- Regular intake of benzodiazepines
- Cognitive impairment: 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...
- people with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- people 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).
- people that exhibit noticeable anxiety and/or claustrophobia.
- people who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- people who have known conditions which can lead to emergency medical care.
- people 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...
- people who have gotten a non-removable piercing or permanent eyeliner.
- people 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 \ 19 on Beck depression inventory.
- people with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- people 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).
- people that exhibit noticeable anxiety and/or claustrophobia.
- people who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- people who have known conditions which can lead to emergency medical care.
- people 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...
- people who have gotten a non-removable piercing or permanent eyeliner.
- people 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).
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.