NCT05150093 Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
| NCT ID | NCT05150093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Laryngeal Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2027-08-31 |
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 120 participants in total. It began in 2022-06-21 with a primary completion date of 2027-08-31.
⚠ 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
The goals of this project are 1) to determine the incidence of neurological voice disorders in patients with dystonia and essential tremor undergoing deep brain stimulation (DBS), 2) investigate the neuroimaging and intracranial neurophysiology correlates of voice dysfunction in these subjects, and subsequently 3) determine the effects of DBS on voice function.
Eligibility Criteria
Inclusion 1. Clinical indications to proceed with DBS implantation, as determined by the clinical multidisciplinary movement disorders board, including: a) definitive diagnosis of essential tremor or dystonia, b) medically refractory disease, c) adequate performance on neuropsychological evaluation as determined by a licensed clinical neuropsychologist. 2. The ability to comply with test directions, complete pre-operative task training, and provide informed consent. 3. Age 18-80 years. Exclusion 1\. Inability to understand or perform the task outlined in the protocol during a pre-surgery training session. 2. Significant hearing loss. 3\. Cortical venous anatomy that could potentially obstruct ECoG electrode placement, as determined by the surgeon, visualized on pre-op MRI or during surgery.
Contact & Investigator
Kristina Simonyan, MD, PhD
STUDY DIRECTOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT05150093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 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 NCT05150093 currently recruiting?
Yes, NCT05150093 is actively recruiting participants. Contact the research team at simonyan_lab@meei.harvard.edu for enrollment information.
Where is the NCT05150093 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05150093 clinical trial?
NCT05150093 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Kristina Simonyan, MD, PhD at Massachusetts Eye and Ear. The trial plans to enroll 120 participants.