Essential Tremor
Conditions
Keywords
deep brain stimulation
Brief summary
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
Interventions
DEVICEDeep Brain Stimulation
Medtronic 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.
Sponsors
National Institutes of Health (NIH)
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * surgical contraindications to DBS * current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time) * family history of hereditary neurologic disorder, besides essential tremors ET * floating metallic objects in the body * pregnancy * alcohol or substance abuse/dependence in the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectral power recorded during intraoperative electrocorticography (ECoG) | During DBS placement surgery before active DBS | — |
| Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | — |
| Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) | Baseline before DBS implant | 10 items are measured-each is scored from 0-4,higher number indicating more tremor |
| Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | — |
| Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) | Baseline before DBS implant | — |
| Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | — |
| Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tremor amplitude as assessed by accelerometric power | Baseline before DBS is turned off | — |
| Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) | Baseline before DBS implant | It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
Countries
United States
Contacts
Primary ContactMark Amandola
Outcome results
None listed