Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
Launched by NORTHWELL HEALTH · Feb 12, 2021
Trial Information
Current as of May 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how a specific brain stimulation treatment affects people with Essential Tremor, a condition that causes uncontrollable shaking. The study aims to understand changes in the brain's structure and its functioning after the treatment is applied to a part of the brain called the dentato-rubro-thalamic tract (DRTt). Researchers hope to find out how this stimulation can improve the symptoms and quality of life for participants who have not found relief from medications.
To be eligible for the trial, participants should be between the ages of 65 and 74 and need to have a diagnosis of Essential Tremor that significantly impacts their daily life. This means their tremors have not improved with multiple medications or those medications caused unpleasant side effects. However, individuals with other serious neurological or psychiatric conditions, recent brain surgeries, or certain medical issues affecting the brain are not eligible. Participants can expect to receive deep brain stimulation treatment and will be monitored for changes in their tremors and overall brain function throughout the study.
Gender
ALL
Eligibility criteria
- 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.
About Northwell Health
Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Manhasset, New York, United States
Houston, Texas, United States
Patients applied
Trial Officials
Albert J Fenoy, MD
Principal Investigator
Northwell Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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