Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT05150093
Status
Recruiting
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Conditions

  • Dystonia
  • Laryngeal Dystonia
  • Spasmodic Dysphonia
  • Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — PROCEDURE
    Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).

Study Details

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.

Key Dates

Start date
Jun 21, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Electrophysiological signal data collection
    Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.

Primary Outcome Measure

Correlations between brain signals and intraoperative voice and speech production performance. [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital, University of California San Francisco, University of UtahBostonMassachusetts02114
Kristina Simonyan, MD, PhD
[email protected]
617-573-6016
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)

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By research site
Massachusetts General Hospital, University of California San Francisco, University of Utah· Boston, MA

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