Feasibility Study Regarding the Implantation and Use of Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders (Either Obsessive-compulsive Disorder or Major Depression)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Change in Y-BOCS (for OCD)
研究概览
简要总结
From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to capsulotomy in refractory cases of Obsessive-Compulsive Disorder [OCD]. More recently, several studies with DBS in patients with major depression have been initiated. In Belgium, there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable neurostimulators, in these OCD patients.
Although rechargeable neurostimulators are widely used in spinal cord stimulation for pain and DBS for movement disorders, they have not yet been used in DBS for psychiatric disorders population. Several possible problems might arise with the use of rechargeable neurostimulators in this highly specific population.
In this prospective study with a before-after design, we would like to determine if the use of rechargeable neurostimulators is effective, applicable and safe and capable of diminishing the need for neurostimulator replacement procedures.
详细描述
BACKGROUND
Obsessive-Compulsive Disorder [OCD] is a psychiatric disorder with a lifetime prevalence of 2% which is mainly characterized by obsessional ideas and compulsive behaviours and rituals. Many patients show improvement under cognitive behavioural and/or pharmacological treatment. A minority of patients is refractory to all available therapy and may benefit from capsulotomy1.
From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to capsulotomy in refractory cases of OCD (2,3). In Belgium, there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable neurostimulators, in these OCD patients.
STUDY RATIONALE
Some patients with DBS for OCD need very frequent replacements of their neurostimulators (Medtronic Synergy 7427 ® [Synergy], Medtronic Kinetra 7428 ® [Kinetra] , Medtronic Activa PC 37601 ® [Activa PC] ), due to end-of-life of the batteries. This results in frequent re-interventions, probably causing discomfort for the patient, wound problems and infections due to revision surgery scar tissue, hardware problems and increasing costs for the public health system (consultations, hardware devices, surgery and its complications).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DBS for OCD / DBS for MD patients, AND
- •experiencing a beneficial effect of DBS on the psychiatric symptoms, AND
- •needing at least 1 IPG replacement per 18 months, AND
- •in the possibility to give informed consent for this study
排除标准
- •anyone not meeting all the inclusion criteria
结局指标
主要结局
Change in Y-BOCS (for OCD)
时间窗: from 2 years before intervention until 2 years after intervention
Change in mean Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Mean Y-BOCS during the first 2 years after intervention minus mean Y-BOCS during the last 2 years before intervention.
Change in HAM-D (for MD)
时间窗: from 2 years before intervention until 2 years after intervention
Change in Hamilton Depression Rating Scale (HAM-D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.
次要结局
- Change in HAM-D (for OCD)(from 2 years before intervention until 2 years after intervention)
- Change in BDI(from 2 years before intervention until 2 years after intervention)
- Change in GAF(from 2 years before intervention until 2 years after intervention)
- Change in Stimulation Amplitude(from 2 years before intervention until 2 years after intervention)
- Change in Stimulation Frequency(from 2 years before intervention until 2 years after intervention)
- Change in Pulse Width(from 2 years before intervention until 2 years after intervention)
- Change in Contact Configuration(from 2 years before intervention until 2 years after intervention)
- Change in frequency of outpatient clinic contacts at the Psychiatry department(from 2 years before intervention until 2 years after intervention)
- Change in fraction of hospitalized days at the Psychiatry department(from 2 years before intervention until 2 years after intervention)
- Change in frequency of outpatient clinic contacts at the Neurosurgery department(from 2 years before intervention until 2 years after intervention)
- Change in fraction of hospitalized days at the Neurosurgery department(from 2 years before intervention until 2 years after intervention)
- Change in frequency of DBS-related surgical procedures(from initial electrode implantation through study completion (on average approximately 5 years))
- Adverse events(from initial electrode implantation through study completion (on average approximately 5 years))