Deep Brain Stimulation for Voice Disorders in Dystonia and Tremor
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
This study is testing if deep brain stimulation can improve voice problems in people with laryngeal dystonia and essential tremor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05150093 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the incidence of voice disorders in patients with laryngeal dystonia and essential tremor who are undergoing deep brain stimulation (DBS). It will investigate the neuroimaging and neurophysiological correlates of voice dysfunction and assess the effects of DBS on voice function. By utilizing both invasive and non-invasive neuroscience techniques, the study seeks to enhance understanding of how voice control is affected in these patients and to develop targeted strategies for treating voice dysfunction through closed-loop brain stimulation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with a definitive diagnosis of essential tremor or dystonia who have not responded to medical treatment.
Not a fit: Patients with significant hearing loss or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved voice function and communication abilities for patients suffering from neurological voice disorders.
How similar studies have performed: While deep brain stimulation has been effective for limb symptoms in similar conditions, the specific focus on voice dysfunction is relatively novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital, University of California San Francisco, University of Utah — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Kristina Simonyan, MD, PhD
- Email: simonyan_lab@meei.harvard.edu
- Phone: 617-573-6016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.