A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD)
研究概览
简要总结
The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: ≤ 70 years
- •Diagnosis of PD according to MDS clinical diagnostic criteria
- •Onset of first PD motor symptoms ≥ 4 years
- •Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use
- •MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
- •Adaptation of medical therapy has been attempted
- •MoCA ≥ 24 in the meds on condition
- •BDI-II score < 20 in the meds on condition, or Patients with moderately severe depression with a BDI-II between 20 and 28 points, strict consideration must be made with the involvement of a psychiatrist. Patients must be willing and able to comply this.
- •Patients able to understand the study requirements and the treatment procedures
- •Written informed consent before any study-specific tests or procedures are performed
排除标准
- •Surgical contraindications to undergo DBS operation
- •Ongoing severe depression (BDI-II > 28)
- •suicidal ideation (item 9 of BDI-II > 1)
- •Dementia (MoCA < 24) in the meds on condition
- •Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
- •Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
- •Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
- •Any history of recurrent seizures or haemorrhagic stroke
- •Fertile women not using adequate contraceptive methods
- •Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- •Any impairment that would limit subject's ability to participate in the study and perform study procedures
- •Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints
研究组 & 干预措施
DBS-group
Within indication and clinical routine:
bilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment
干预措施: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment (Procedure)
结局指标
主要结局
Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD)
时间窗: 12 months
Difference of change (improvement) from baseline to follow-up between the two treatment groups with respect to the hyperdopaminergic sub-score
次要结局
- Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication(12 months)
- Patient Global Impression (PGI-S, Severity) (PGI-C, Change)(12 months)
- Starkstein-Apathy-Scale (SAS)(12 months)
- suicidal item 9 of the BDI(12 months)
- Neuropsychiatric-fluctuations scale (NFS)(12 months)
- Young mania rating scale (YMRS)(12 months)
- Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index(12 months)
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS)(12 months)
- Hospital Anxiety and Depression Scale (HADS)(12 months)
- MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable(12 months)
- Beck Depression Inventory (BDI)(12 months)
- Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version(12 months)
- Marconi Dyskinesia Rating Scale(12 months)
- Pittsburgh Sleep Quality Index (PSQI)(12 months)
- Safety weight monitoring (BMI control)(12 months)
- Clinical Global Impression (CGI-S, Severity) (CGI-C, Change)(12 months)
- Parkinson's disease Dysarthria Compound Score (PD-DCS)(12 months)
- Montreal Cognitive Assessment (MoCA)(12 months)
- Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment)(12 months)
- Adverse events(12 months)
研究者
Steffen Paschen
Dr. med.
University of Kiel