Understanding brain changes in essential tremor after deep brain stimulation
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
NA · Northwell Health · NCT04758624
This study is testing how deep brain stimulation affects brain connections in people with essential tremor who haven't found relief from medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT04758624 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the structural and functional connectivity changes in the dentato-rubro-thalamic tract (DRTt) following deep brain stimulation (DBS) in patients with essential tremor. By utilizing advanced imaging techniques, the research will assess how DBS affects brain connectivity and potentially improves tremor symptoms. The study focuses on patients whose tremors have not responded to medication and significantly impact their quality of life. The findings could provide insights into the mechanisms of DBS and its effects on brain function.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with essential tremor that is refractory to medication and severely impacts their quality of life.
Not a fit: Patients with significant neurological disorders, severe psychiatric illnesses, or those who have had previous surgeries targeting the brain region of interest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from essential tremor.
How similar studies have performed: Other studies have shown promising results with deep brain stimulation for essential tremor, indicating that this approach is well-supported in the literature.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manhasset, New York
- North Shore University Hospital — Manhasset, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Albert J Fenoy, MD — Northwell Health
- Study coordinator: Mark Amandola
- Email: mamandola@northwell.edu
- Phone: 516 491 1054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Essential Tremor, deep brain stimulation