Brain Stimulation for Patients With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Motor manifestations of Parkinson Disease
研究概览
简要总结
The aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; TPS) in adults with Parkinson Disease (PD). Participants will receive 6 sessions of TPS and Sham-TPS, respectively, in random order. Motor manifestations of PD and manual dexterity will be the primary outcome measures. Outcomes will be assessed immediately post-treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically stable PD with fine skilled and/or gross motor deficits (e.g. right arm with a clinical force level >2)
- •Signed written informed consent
- •Monthly pregnancy test for women in childbearing years
- •Age >= 18 years
排除标准
- •Non-compliance with the protocol
- •Pregnant or breastfeeding women
- •Relevant intracerebral pathology unrelated to the disease (e.g. Brain tumor)
- •Hemophilia or other blood clotting disorders
- •Cortisone treatment within the last 6 weeks before first treatment
- •Thrombosis
结局指标
主要结局
Motor manifestations of Parkinson Disease
时间窗: 1 month post-treatment
Motor manifestations of Parkinson Disease will be rated by an examiner using the relevant subscale (section III) of the Unified Parkinson Disease Rating Scale (UPDRS). This scale has 14 different types of ratings, with many of these ratings done independently for the different limbs (tremor at rest, action tremor, rigidity, bradykinesia, speech, facial expression, arising from a chair, posture, gait, postural stability, body bradykinesia). Each of the ratings ranges from 0 (normal) to 4 (severe manifestation). The total score for this scale ranges from 0 to 108, the sum of scores from 27 observations (Perlmutter 2009).
Manual dexterity
时间窗: 1 month post-treatment
Deficits in fine skilled movements will be assessed by the coin rotation test (Foki et al., 2010). A coin hast to be flipped with the first 3 fingers of one hand as fast as possible for 30 seconds. The number of successful half rotations will be determined.
次要结局
- Montreal Cognitive Assessment (MOCA)(1 month post-treatment)
- Bayer Activities of Daily Living Scale (B-ADL)(1 month post-treatment)
- Leisure Behavior (FZV; German: Freizeitverhalten)(1 month post-treatment)
- Geriatric Depression Scale - short form (GDS-15)(1 month post-treatment)
- Beck Depression Inventory (BDI)(1 month post-treatment)
- Activities of daily living (ADL)(1 month post-treatment)
- Somatosensory evoked EEG Potentials (SEPs)(Immediately post-stimulation)
- Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)(Immediately post-treatment)