Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application (NCT05506085) | Clinical Trial Compass
RecruitingNot Applicable
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
United States12 participantsStarted 2022-10-01
Plain-language summary
Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
* Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
* Age range of 18-80 years
* Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
* No evidence for dementia as assessed by neurologist.
* No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score \> 29, Beck Anxiety Inventory Score \> 26.
* At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.
Exclusion Criteria:
* Individuals younger than 18 years and older than 80 years of age.
* Women who plan to become pregnant during the study period or are currently breastfeeding.
* Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
* Prior laryngeal framework surgeries or other disorders affecting the vocal folds
* Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
* Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
* Gagging or discomfort that would preclude the placement of the endoscope to vis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in total number of Vocal fold movements
Timeframe: Before surgery, within 24 hours after surgery, 6 -9 months after surgery
2
Change in Acoustic voice recordings
Timeframe: Before surgery, within 24 hours after surgery, 6-9 months after surgery