RecruitingNot ApplicableNCT04758624

Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract

Sponsor

Northwell Health

Enrollment

72 participants

Start Date

Dec 4, 2021

Study Type

INTERVENTIONAL

Conditions

Essential Tremor

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

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 Criteria10

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.

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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.

Locations(1)

North Shore University Hospital

Manhasset, New York, United States

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NCT04758624

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