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 — DEVICE
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Albert Fenoy
Prashin Unadkat (SUB_INVESTIGATOR)

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