Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Deep Brain Stimulation
Procedure/SurgeryClinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Electrophysiological signal data collectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlations between brain signals and intraoperative voice and speech production performance.
Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.
Time frame
5 years2
Changes in standard clinical outcome for dystonia patients
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.
Time frame
5 years3
Changes in standard clinical outcome for tremor patients
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.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts Eye and Ear Infirmary
Lead sponsor
Massachusetts General Hospital
Collaborator
University of Utah
Collaborator
University of California, San Francisco
Collaborator
UMass Memorial Health
Collaborator
University of Iowa
Collaborator
Source ClinicalTrials.gov