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Search / Trial NCT05150093

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Nov 27, 2021

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called deep brain stimulation (DBS) on patients with voice disorders linked to conditions like laryngeal dystonia and essential tremor. Researchers want to find out how common these voice problems are in patients who are already getting DBS for their movement disorders. They will also look at brain imaging and electrical activity in the brain to understand why these voice issues happen and how DBS might help improve voice function.

To participate in this trial, you need to be between 18 and 80 years old and have a confirmed diagnosis of essential tremor or dystonia that hasn't responded well to other treatments. You also need to be able to follow instructions and complete some training before the surgery. If you decide to join, you will undergo evaluations to see if you qualify, and if you do, you’ll receive DBS and be monitored for changes in your voice. This trial is currently recruiting participants, and it's a chance to contribute to understanding how to better support individuals with voice problems related to these conditions.

Gender

ALL

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.

About Massachusetts Eye And Ear Infirmary

Massachusetts Eye and Ear Infirmary is a leading academic medical center specializing in the diagnosis and treatment of eye, ear, nose, and throat disorders. Affiliated with Harvard Medical School, the institution is renowned for its commitment to advancing clinical research and innovative therapies in ophthalmology, otology, and related fields. With a focus on improving patient outcomes, the infirmary conducts a variety of clinical trials aimed at enhancing understanding of diseases and developing cutting-edge treatment options. Its multidisciplinary team of experts collaborates closely with patients and research partners to ensure the highest standards of care and scientific integrity.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Kristina Simonyan, MD, PhD

Study Director

Massachusetts Eye and Ear

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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