Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study
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
- DextQ-24
研究概览
简要总结
We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.
详细描述
Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
rTMS protocol either sham or real
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
- •Confirmed PD
- •Hoehn & Yahr I to IV
- •Age 50-80 years old
- •written and signed informed consent
- •dexterous difficulties-
排除标准
- •Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21)
- •Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems)
- •Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history.
- •Participation in another interventional trial.
研究组 & 干预措施
real stimulation
The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.
干预措施: Transcranial magnetic stimulation (Other)
sham stimulation
The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.
干预措施: Sham transcranial magnetic stimulation (Other)
结局指标
主要结局
DextQ-24
时间窗: 3 weeks
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD
次要结局
- Coin rotation task (CRT)(3 weeks)
- Nine Hole Peg test (9-HPT)(3 weeks)