About this trial
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
distal appendicular tremor, with minimal proximal component
tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
tremor judged to be severely impacting their quality of life.
Disqualifiers
significant neurological disorder
significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
severe psychiatric illness with suicidal ideations
previous surgery to destroy the target region of the brain
Trial design
Single group
Treatments tested in this trial
Deep Brain Stimulation
DeviceMedtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.
Treatment groups
Trial outcomes
Primary outcomes
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Secondary outcomes
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwell Health
Lead sponsor
National Institutes of Health (NIH)
Collaborator