Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT04758624
- Status
- Recruiting
Conditions
- Essential Tremor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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
Key Dates
- Start date
- Dec 4, 2021
- Status verified
- Apr 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Deep Brain Stimulation(DBS)
Primary Outcome Measure
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: Baseline before DBS implant ]
Central Contacts
- Mark Amandola516 491 1054
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | Albert Fenoy Prashin Unadkat (SUB_INVESTIGATOR) |
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