Recruiting

Deep Brain Stimulation

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05150093

Conditions

Laryngeal Dystonia

Spasmodic Dysphonia

Tremor

Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

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.

Conditions

Laryngeal Dystonia

Spasmodic Dysphonia

Tremor

Dystonia

Study ID

NCT05150093

Start date

Jun 21, 2022

Status verified date

Nov, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Deep Brain Stimulation

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

Primary outcome measure

  • Correlations between brain signals and intraoperative voice and speech production performance. [ Time Frame: 5 years ]
  • Changes in standard clinical outcome for dystonia patients [ Time Frame: 5 years ]
  • Changes in standard clinical outcome for tremor patients [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kristina Simonyan, MD, PhD

617-573-6016simonyan_lab@meei.harvard.edu

Locations

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kristina Simonyan, MD, PhD

617-573-6016simonyan_lab@meei.harvard.edu

Principal Investigator:

Julie Barkmeier-Kraemer, PhD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-12-02.