Clinical Research Directory
Browse clinical research sites, groups, and studies.
Directional Bilateral Thalamic Patterned Stimulation (Chronos)
Sponsor: Alfonso Fasano
Summary
Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads. Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor. Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.
Official title: Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-07-16
Completion Date
2027-01-01
Last Updated
2024-11-04
Healthy Volunteers
No
Conditions
Interventions
DBS programing
The physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients.
Locations (1)
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada