RecruitingNot ApplicableNCT05150093

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor


Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

120 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Inclusion
  • 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.
  • The ability to comply with test directions, complete pre-operative task training, and provide informed consent.
  • Age 18-80 years.
  • Exclusion
  • \. Inability to understand or perform the task outlined in the protocol during a pre-surgery training session. 2. Significant hearing loss.
  • \. Cortical venous anatomy that could potentially obstruct ECoG electrode placement, as determined by the surgeon, visualized on pre-op MRI or during surgery.

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Interventions

PROCEDUREDeep Brain Stimulation

Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).


Locations(1)

Massachusetts General Hospital, University of California San Francisco, University of Utah

Boston, Massachusetts, United States

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NCT05150093


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