Randomised, Double-Blind, Crossover Clinical Trial Comparing Bilateral Deep Brain Stimulation of the Posterior Subthalamic Area Versus the Ventral Intermediate Nucleus of the Thalamus in Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Improvement in tremor assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) total score
研究概览
简要总结
Deep brain stimulation (DBS) of both ventral intermediate nucleus (VIM) and the posterior subthalamic area (PSA) has shown to be an effective treatment for essential tremor (ET). Characterizing the differences between both targets is necessary. The aim of the study is comparison of efficacy, safety, energy efficiency, neuropsychological status and quality of life of bilateral PSA-DBS vs bilateral VIM-DBS in the treatment of ET. The study hypothesis is that PSA-DBS is not inferior to VIM-DBS in terms of efficacy in controlling tremor, but has superior energy efficiency and safety.
详细描述
Deep brain stimulation (DBS) of the ventral intermediate (VIM) nucleus of the thalamus is an effective treatment for disabling essential tremor (ET). In recent years, the posterior subthalamic area (PSA) has emerged as a potentially more effective target. There is a need for specific research into the clinical efficacy, efficiency, as well as the mid-term cognitive and quality-of-life outcomes of VIM-DBS and PSA-DBS. The aim of this study is: 1) to compare the efficacy and safety of bilateral PSA-DBS versus bilateral VIM-DBS in the treatment of ET. 2) to determine the impact of bilateral PSA-DBS versus bilateral VIM-DBS on quality of life, neuropsychological status, energy efficiency of the DBS system, and durability of the tremor-suppressing effect. The hypothesis is that PSA-DBS is not inferior to VIM-DBS in terms of efficacy in controlling tremor, but has superior energy efficiency and safety. To this end, a randomized, double-blind, crossover trial will be conducted, in which bilateral octopolar DBS leads will be implanted in a single-trajectory covering the VIM and PSA in patients with disabling and refractory ET. They will be randomly assigned to group 1 (PSA-VIM) or group 2 (VIM-PSA), undergoing stimulation on each target for 3 months. A blinded assessment will be carried out at the end of each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of bilateral ET or ET-plus according to the Movement Disorders Society criteria.
- •Refractoriness to medication: at least two attempts at medical treatment with at least two groups of different medication (fundamentally propranolol and primidone), which were ineffective (insufficient tremor control or adverse effects).
- •Subjects of both sexes, older than 18 years old.
- •Sufficient competence to collaborate and comply with the study protocols.
- •Ability to provide informed consent.
排除标准
- •Clinically relevant cognitive decline which may interfere with the study.
- •Clinically relevant active psychiatric disorder.
- •Contraindication for general surgery or bilateral DBS.
- •Unsuitable electrode location according to neuroimaging.
- •Participation in other interventional study.
- •Cerebral atrophy (width of the third ventricle >10 mm) or other anatomical anomalies that would interfere with optimal stereotactic localization.
研究组 & 干预措施
VIM-DBS
Stimulation delivered to VIM
干预措施: Deep Brain Stimulation (DBS) (Device)
PSA-DBS
Stimulation delivered to PSA
干预措施: Deep Brain Stimulation (DBS) (Device)
结局指标
主要结局
Improvement in tremor assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) total score
时间窗: - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)
Improvement from baseline to the end of the VIM-DBS vs PSA-DBS period, assessed as the FTM-TRS total score (0-144 points; higher scores indicate greater tremor severity).
次要结局
- Stimulation efficiency assessed by stimulation amplitudes (mA)(4 postoperative months (after the first 3-month stimulation period) and 7 postoperative months (after the second 3-month stimulation period))
- Stimulation efficiency measured by total electrical energy delivered (TEED)(4 postoperative months (after the first 3-month stimulation period) and 7 postoperative months (after the second 3-month stimulation period))
- Quality of life (QoL) assessed using Visual Analog Scale (VAS)(- Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period))
- Quality of life (QoL) assessed using the Quality of life in essential tremor questionnaire (QUEST)(- Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period))
- Number and type of stimulation-induced side effects(- 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period))
- Overall cognitive assessment evaluated using the Dementia Rating Scale 2 (DRS-2)(- Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period))
研究者
Lucía Triguero Cueva
Investigadora colaboradora, doctoranda.
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental