What this study is
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.
What's being tested
- Deep Brain Stimulation
Intervention · PROCEDURE
Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).
Study details
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Laryngeal Dystonia · Spasmodic Dysphonia · Tremor · Dystonia
- Enrolling
- 120 people
- Starts
- 2022-06-21
- Est. completion
- 2027-08-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital, University of California San Francisco, University of Utah
Boston, Massachusetts, United States
- Kristina Simonyan, MD, PhD · Contact617-573-6016simonyan_lab@meei.harvard.edu
- Julie Barkmeier-Kraemer, PhD · Principal investigator
- Ian Bledsoe, MD, MS · Principal investigator
- Shervin Rahimpour, MD · Principal investigator
- Jeremy Greenlee, MD · Principal investigator
- Farid Hamzei-Sichani, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts Eye and Ear Infirmary
Study ID 2021P003236
Study director
Kristina Simonyan, MD, PhD
Massachusetts Eye and Ear
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.