Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease: Design of a Two-armed Double-blind Cross-over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 'Axial score'
研究概览
简要总结
12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata [STN+SNr].
详细描述
A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts [STN+SNr] in refractory hypokinetic gait disturbances compared with [STNmono] (active comparator). The results will clarify, whether the combined [STN+SNr] stimulation improves otherwise refractory gait disturbances in PD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age: between 18 and 80 years
- •Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
- •Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
- •Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical [MedOn/STNmono] condition ≥ 12
- •Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
- •Dopaminergic medication constant for at least four weeks prior to study enrolment
- •Disease duration ≥ 5 years
排除标准
- •Cognitive impairment (Mini Mental State Exam < 25)
- •Participation in other clinical trials within the past three months and during enrolment in our study
- •Suicidality, Psychosis
- •Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
- •Pregnancy
- •Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol
结局指标
主要结局
'Axial score'
时间窗: Three weeks after active treatment (STN vs. STN+SNr), respectively
The composite 'axial score' is built by 8 items from the UPDRS II and III, all 5-point rated (0 to 4) representing increasing levels of pathology. The 'axial score' will be scored by the sum of the ratings across the 8 items (Range 0 to 32). As change in UPDRS scores is a common primary efficacy outcome measure in Parkinson's disease and only items of the original UPDRS are required for the definition of the primary endpoint, the statistical evaluation methods should be based on the psychometric validation of the UPDRS and no own validation studies are necessary. Safety: falls
次要结局
- CAPSIT-PD(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Freezing of gait assessment course(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Freezing of gait questionnaire(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Berg Balance Scale(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Non-motor symptoms scale(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Non-motor symptoms quest(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Beck's depression scale index(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Minnesota Impulsive Disorders Interview(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- Barratt Impulsiveness Scale(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- UPDRS I-IV(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
- PDQ-39(At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively)
研究者
Daniel Weiss
MD
University Hospital Tuebingen