Deep braIn Stimulation for Tremor TractographIC Versus Traditional
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline
研究概览
简要总结
This is a monocentric, randomized, controlled, 2 arms, interventional, observer-blinded feasibility trial.
Patients suffering from essential tremor (ET) will be treated with Deep Brain Stimulation (DBS). For the implantation of the DBS electrodes and the DBS system (Activa INS, Medtronic) patients will randomized either to conventional stereotactic surgery of thalamic/subthalamic region with short anesthesia or to MR-tractography guided stereotactic surgery with target point of the dentato-rubro-thalamic bundle (DRT) in general anesthesia.
Patients will visit the study center at screening, baseline/neurosurgery, six and twelve months after neurosurgery.
详细描述
In this monocentric, randomized, controlled, 2 arms, interventional, observer-blinded feasibility trial patients suffering from therapy resistant essential tremor (ET) will be treated with Deep Brain Stimulation (DBS).
After screening (e.g. obtaining informed consent, assessment of inclusion/exclusion criteria etc.) patients will be randomized to one of the following groups:
Group 1 (conventional):
Conventional AC-PC based DBS implantation in the thalamic/subthalamic region (Vim-cZI) starting as awake surgery with a brief general anesthesia for stimulator implantation at the end of surgery.
Group 2 (tractographic):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥ 25 and ≤ 80 years
- •Patients with Essential Tremor according to the criteria of the consensus statement of the movement disorders society (Deuschl et al. 1998) are included with a medical treatment resistant and disabling postural and/or intentional tremor.
- •FTMTRS to be completed within 42 days prior surgery
- •Stable tremor medication for at least 3 months prior inclusion
- •Written informed consent
排除标准
- •Major Depression with suicidal thoughts or suicidal thoughts in history
- •Dementia (Mattis Dementia Rating Score ≤ 130)
- •Acute psychosis
- •Patient incapability
- •Nursing care at home
- •Surgical contraindications
- •Medications that are likely to cause interactions in the opinion of the investigator
- •Known or persistent abuse of medication, drugs or alcohol
- •Persons who are in a relationship of dependence/employment with the sponsor or the investigator
- •Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
- •Current or planned pregnancy, nursing period
结局指标
主要结局
Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline
时间窗: Baseline, 6 months after neurosurgery
Tremor reduction defined by the difference in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) at 6 months after intervention to baseline
次要结局
- Size of VAT(Day 0 (Day of neurosurgery))
- Assessment of (Serious) Adverse Events related to intervention(Up to 12 months after neurosurgery)
- Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention(Baseline, 6 and 12 months after neurosurgery)
- Effective tremor reduction at 12 months after intervention(Baseline, 12 months after neurosurgery)
- Quality of Life: QUEST, SF-36(Baseline, 6 and 12 months after neurosurgery)
- Changes in BDI(Baseline, 6 and 12 months after neurosurgery)
- Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention(Baseline, 6 and 12 months after neurosurgery)
- Effective contact position with respect to DRT and AC-PC coordinates(Day 0 (Day of neurosurgery))
- Duration of neurosurgery(Day 0 (Day of neurosurgery))
研究者
Prof. Dr. Volker Arnd Coenen
Prof. Dr. med.
University Hospital Freiburg