Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor

Alfonso Fasano1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2024年7月16日最近更新: 2024年11月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 15
试验地点: 1
主要终点: Tremor analysis (meter per second squared)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Phase 1: 5 to 10 tremor patients already treated with VIM-DBS but not doing well due to early and/or late loss of benefits (i.e. tremor scores ON stimulation identical or greater than before surgery in absence of stimulation).
•Phase 2: 10 Essential Tremor patients in need of DBS surgery.
•Written and signed Informed Consent.
•Age 18 to 85 years old.
•Subject must have Essential Tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral action tremor; (b) at least three years duration; and (c) with or without tremor in other locations (e.g., head, voice, or low limbs) [1].
•Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart.
•Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening.
•Subject had no botulinum injection for at least three months prior to screening.
•Subject does not have a significant other medical condition biasing the study finding in investigator's opinion.

排除标准

•Unwilling or inability to follow the procedures specified by the protocol.
•Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol.
•Untreated clinically significant depression.
•Any current drug or alcohol abuse, as determined by the investigator.
•History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator.
•Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
•Any terminal illness with life expectancy of < 12 months.
•Participation in any other interventional clinical trial (e.g. drug, device).

研究组 & 干预措施

Phase 1

Experimental

5 to 10 patients with tremor already treated with VIM-DBS but not doing well because of early or late loss of benefits will be recruited by the PI over a 6 months period. If interested, the potential participants will be screened, informed, and consented by a research coordinator. Before the replacement of their IPG (implantable pulse generator), a baseline measurement will be performed.

干预措施: DBS programing (Other)

Phase 2

Experimental

Ten patients with ET needing DBS-VIM surgery will be recruited and will receive Boston Scientific Genus IPG bilaterally connected to Boston Scientific Cartesia™ 8-contact Directional Leads. The programming will be done in four different settings/periods during the course of 8 months.

干预措施: DBS programing (Other)