Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
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|ClinicalTrials.gov Identifier: NCT05150093|
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : April 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Laryngeal Dystonia Spasmodic Dysphonia Tremor Dystonia||Procedure: Deep Brain Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor|
|Actual Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||August 31, 2026|
|Estimated Study Completion Date :||August 31, 2026|
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.
Procedure: Deep Brain Stimulation
Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).
- Correlations between brain signals and intraoperative voice and speech production performance. [ Time Frame: 5 years ]Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.
- Changes in standard clinical outcome for dystonia patients [ Time Frame: 5 years ]Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Burk-Fahn-Marsden Dystonia Rating Scale where higher score means a worse outcome.
- Changes in standard clinical outcome for tremor patients [ Time Frame: 5 years ]Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Fahn-Tolosa-Marin Tremor Rating Scale where higher score means a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05150093
|Contact: Husam Hammad, MS, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital, University of California San Francisco, University of Utah||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Husam Hammad, MS, MPH 617-573-6016 email@example.com|
|Principal Investigator: Robert M Richardson, MD, PhD|
|Principal Investigator: Doris Wang, MD, PhD|
|Principal Investigator: John Rolston, MD, PhD|
|Study Director:||Kristina Simonyan, MD, PhD||Massachusetts Eye and Ear|