Effects of the Combination of Physical Exercise and Transcranial Direct Current Stimulation on Motor Function and Underlying Neurophysiological Mechanisms in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gait Speed at Preferred Speed
研究概览
简要总结
A controlled, blinded, and randomized clinical study will be carried out in a large sample of people with Parkinson's disease, where the combined effects of physical exercise and transcranial direct curren stimlation (tDCS) on motor function will be evaluated.
详细描述
Parkinson's disease (PD) is a neurological disease whose motor symptoms drastically affect the quality of life of those who suffer from it. There is currently high scientific evidence of the positive effect of physical exercise on the motor function of people with PD. This effect seems to be more relevant when this physical exercise is implemented with external sensory signals (eg visual, auditory). However, the neurophysiological mechanisms underlying these improvements induced by physical exercise are still unknown. It should also be noted that in recent years the simultaneous combination of physical exercise and transcranial direct current stimulation (tDCS) has begun to be explored, a non-invasive cortical neuromodulation technique that could enhance these positive effects of physical exercise. Up to now, the studies are few and have numerous methodological limitations to be able to confirm this potentiating effect of tDCS. In this project, a controlled, blinded, and randomized clinical study will be carried out in a large sample of people with PD, where the combined effects of physical exercise and tDCS on motor function will be evaluated. Using electrophysiological techniques (electroencephalography and transcranial magnetic stimulation), the possible neurophysiological mechanisms underlying the possible motor improvements found and their role in the processes of preparation and motor activation and synaptic plasticity will also be explored. The relevance of this study is twofold: i) on the one hand it will allow us to understand the movement control mechanisms that can be improved with physical exercise and thus allow us to develop more specific exercise programs in PD and ii) to know if the use of tDCS can enhance these benefits, thus opening a new therapeutic avenue in Parkinson's disease. Lastly, and taking into account that Parkinson's disease is the second most prevalent neurodegenerative disease, the results of this study may have a great impact on this group through a viable transfer to the social and health field.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of idiopathic Parkinson's disease, established according to the UK Parkinson's Disease Society Brain Bank Criteria.
- •Ability to understand and comply with study procedures.
- •Stable antiparkinsonian medication regimen prior to study participation.
排除标准
- •Significant cognitive impairment, defined as a score < 23 on the Mini-Mental State Examination (MMSE).
- •Below-average premorbid intelligence, defined as a score < 40 on the Vocabulary subtest of the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III).
- •Clinically significant depression, defined as a score > 10 on the Geriatric Depression Scale (GDS-15).
- •Current treatment with cholinesterase inhibitors.
- •Presence of severe cardiovascular disease, including but not limited to:
- •Congestive heart failure
- •Ischemic heart disease
- •Cardiac pacemaker
- •Orthostatic hypotension
- •Uncontrolled diabetes mellitus.
- •History of stroke or traumatic brain injury.
- •History of seizure disorder or epilepsy.
- •Presence or prior implantation of a deep brain stimulation (DBS) device.
- •History of major orthopedic surgery that could interfere with motor performance or gait.
- •Presence of implanted electronic devices, including cardiac pacemakers, incompatible with study procedures.
研究组 & 干预措施
realtDCS&exercise Group
24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
干预措施: real tDCS and exercise (Other)
shamtDCS&exercise Group
24 sessions of reactive exercise simulatenously with sham tDCS over the motor cortex contralteral to the most affected side.
干预措施: Sham tDCS and exercise (Other)
Exercise Group
24 sessions of reactive exercise.
干预措施: Exercise (Other)
Control Group
No interventio. Only evaluations before and after 5 weeks time.
结局指标
主要结局
Gait Speed at Preferred Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Gait speed assessed during walking at preferred speed using the OptoGait System. Units m/s
Step length at Preferred Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Step length assessed during walking at preferred speed using the OptoGait System. Units meters
Cadence at Preferred Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Cadence assessed during walking at preferred speed using the OptoGait System. Units steps/min
Gait Speed at Maximal Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Gait speed assessed during walking at maximal speed using the OptoGait System. Units m/s
Step Length at Maximal Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Step length assessed during walking at maximal speed using the OptoGait System. Units meters
Cadence at Maximal Speed
时间窗: From enrollment to the end of treatment at 7 weeks
Cadence assessed during walking at maximal speed using the OptoGait System. Units steps/minute
Timed Up and Go test performance
时间窗: From enrollment to the end of treatment at 7 weeks
Functional mobility assessed using the Timed Up and Go (TUG) test. The outcome is defined as the time required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. Performance is expressed in seconds, with lower values indicating better functional mobility.
Choice stepping reaction time
时间窗: From enrollment to the end of treatment at 7 weeks
Choice stepping reaction time assessed using an adapted Choice Stepping Reaction Time (CSRT) test. Participants stood on a platform and were instructed to step as quickly as possible onto one of four target devices in response to a visual stimulus. Four electronic sensor-based devices were positioned in front of and to the side of each foot. Participants responded using the left foot for left-side targets and the right foot for right-side targets. Reaction time was defined as the time elapsed between stimulus onset and foot contact with the target device, recorded in milliseconds. The outcome corresponds to the mean reaction time across 20 stimuli.
Choice arm reaching reaction time
时间窗: From enrollment to the end of treatment at 7 weeks
Choice arm reaching reaction time assessed using an adapted choice reaction time task. Participants were seated and instructed to reach as quickly as possible toward one of four target devices placed on a table in response to a visual stimulus. Targets were arranged in front of and to the side of each hand. Participants responded using the left hand for left-side targets and the right hand for right-side targets. Reaction time was defined as the time elapsed between stimulus onset and hand contact with the target device, recorded in milliseconds. The outcome corresponds to the mean reaction time across 20 stimuli.
次要结局
- Grooved pegboard test(From enrollment to the end of treatment at 7 weeks)
- Path Length With Eyes Open Without Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Path Length With Eyes Closed Without Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Path Length With Eyes Open With Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Path Length With Eyes Closed Witht Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Sway Radius With Eyes Open Without Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Sway Radius With Eyes Closed Without Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Sway Radius With Eyes Open With Cognitive Task(From baseline to the end of treatment at 7 weeks)
- Sway Radius With Eyes Closed With Cognitive Task(From baseline to the end of treatment at 7 weeks)
研究者
Miguel Fernández del Olmo
Professor
Universidad Rey Juan Carlos