Status:
RECRUITING
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Essential Tremor
Eligibility:
All Genders
18-85 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04758624
Start Date
December 4 2021
End Date
August 31 2026
Last Update
April 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
North Shore University Hospital
Manhasset, New York, United States, 11030