Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Technical feasibility of new electrode implantation
研究概览
简要总结
The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.
详细描述
Deep brain stimulation (DBS) is a validated therapy for treating dystonia and other movement disorders. The main therapeutical target used for treating dystonic syndromes is the internal globus pallidum (GPi). Given the morphology and the topography of this nucleus and, based on the experience of an efficient therapy by using only one or two contacts out of the available four contacts of the standard DBS lead, we designed two new electrodes, one one contact-electrode and one two contact-electrodes, with the aim to limit side effects related to internal globus pallidum DBS and to provide a more homogeneous electric field around the electrode within the GPi and maintaining the same therapeutical outcome.
The main objective of the trial is to study the technical feasibility of the implantation of a new one contact-electrode (Monopolar DBS Lead Model 09064-40cm) for treating isolated generalized/segmental dystonia or tardive dystonia.
The second main objective of the study is to assess the safety of the implantation of the new device.
The secondary objective is to explore the therapeutical effect of DBS using the new monocontact electrode and to study the electrical field generated around the monocontact electrode within the GPi.
The study is prospective and patients are recruited from a Tertiary Movement Disorders Clinic. Seven subjects will be recruited for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age superior to 18 years and inferior to 65 years
- •Generalized or segmental isolated dystonia or tardive dystonia
- •Diagnosis is based on history, clinical examination, check-up without abnormalities and normal brain MRI allowing exclusion of secondary and degenerative dystonias
- •Unsufficient response to pharmacological treatment (improvement < 30/% on clinical dystonia scales)
- •No comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial
- •Consent of the patient
- •Insurance affiliation
- •Follow-up possible for 12 months
- •Available insurance for the operated patient
排除标准
- •No possibility for clinical follow-up
- •Acquired dystonia except for tardive dystonia
- •MRI or generalized anesthesia contraindicated
- •Anticoagulant treatment or antiaggregant treatment
- •Pregnancy
- •Ongoing participation to another clinical trial
- •Guardianship or Trusteeship
- •Person deprived of liberty
研究组 & 干预措施
Electrode deep brain stimulation
Monocontact electrode deep brain stimulation
干预措施: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm) (Device)
结局指标
主要结局
Technical feasibility of new electrode implantation
时间窗: One year
The feasibility of the implantation is evaluated by stereotaxic frame placement, site of incision, burr hole size and location, technique for insertion, connection with the extension cables to the neurostimulator, measure of the impedances, duration of the surgery, MRI control for lead position, comparison of the artefacts of the leads with the artefacts of the standard electrodes.
Safety of new electrode implantation (evaluated by the occurence of side effects)
时间窗: One year
The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.
次要结局
- clinical effect of deep brain stimulation using one contact-electrodes (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale)(One year)