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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients.
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada
RECRUITINGTremor Rating Scale (Part A-B)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Time frame: Phase 1-Baseline
Tremor analysis
Using accelerometers
Time frame: Phase 1-Baseline
Tremor Rating Scale (A-C)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tremor analysis (meter per second squared)
Using accelerometers
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait speed (meter per second)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Base of support (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Step length (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Stride length (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Single stance time and double stance time (seconds)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tandem gait
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Posturography (newtons)
Using Proteokinetics Zeno System
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Quality of life in Essential Tremor Questionnaire (QUEST)
Range from 0-40, with 0 representing no tremor and 40 representing severe tremor.
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Speech analysis
automated analysis pipeline in MatLab
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
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