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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
24 sessions of reactive exercise with sham tDCS
24 sessions of reactive exercise
Center of Sport Research
Fuenlabrada, Madrid, Spain
RECRUITINGGait Speed at Preferred Speed
Gait speed assessed during walking at preferred speed using the OptoGait System. Units m/s
Time frame: From enrollment to the end of treatment at 7 weeks
Step length at Preferred Speed
Step length assessed during walking at preferred speed using the OptoGait System. Units meters
Time frame: From enrollment to the end of treatment at 7 weeks
Cadence at Preferred Speed
Cadence assessed during walking at preferred speed using the OptoGait System. Units steps/min
Time frame: From enrollment to the end of treatment at 7 weeks
Gait Speed at Maximal Speed
Gait speed assessed during walking at maximal speed using the OptoGait System. Units m/s
Time frame: From enrollment to the end of treatment at 7 weeks
Step Length at Maximal Speed
Step length assessed during walking at maximal speed using the OptoGait System. Units meters
Time frame: From enrollment to the end of treatment at 7 weeks
Cadence at Maximal Speed
Cadence assessed during walking at maximal speed using the OptoGait System. Units steps/minute
Time frame: From enrollment to the end of treatment at 7 weeks
Timed Up and Go test performance
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.
Time frame: From enrollment to the end of treatment at 7 weeks
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Choice stepping reaction time
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.
Time frame: From enrollment to the end of treatment at 7 weeks
Choice arm reaching reaction time
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.
Time frame: From enrollment to the end of treatment at 7 weeks
Grooved pegboard test
Manual dexterity assessed using the Grooved Pegboard test. Participants were instructed to place key-shaped pegs into a grooved board as quickly as possible using one hand. Performance was defined as the time required to correctly place all pegs into the board, expressed in seconds. Lower completion times indicate better manual dexterity.
Time frame: From enrollment to the end of treatment at 7 weeks
Path Length With Eyes Open Without Cognitive Task
Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and without a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter
Time frame: From baseline to the end of treatment at 7 weeks
Path Length With Eyes Closed Without Cognitive Task
Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes closed and without a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter
Time frame: From baseline to the end of treatment at 7 weeks
Path Length With Eyes Open With Cognitive Task
Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and with a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter
Time frame: From baseline to the end of treatment at 7 weeks
Path Length With Eyes Closed Witht Cognitive Task
Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes closed and with a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter
Time frame: From baseline to the end of treatment at 7 weeks
Sway Radius With Eyes Open Without Cognitive Task
Center of pressure sway radius, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and without a concurrent cognitive task. Higher values indicate poorer postural stability.
Time frame: From baseline to the end of treatment at 7 weeks
Sway Radius With Eyes Closed Without Cognitive Task
Center of pressure sway radius, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes closed and without a concurrent cognitive task. Higher values indicate poorer postural stability.
Time frame: From baseline to the end of treatment at 7 weeks
Sway Radius With Eyes Open With Cognitive Task
Center of pressure sway radius, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and with a concurrent cognitive task. Higher values indicate poorer postural stability.
Time frame: From baseline to the end of treatment at 7 weeks
Sway Radius With Eyes Closed With Cognitive Task
Center of pressure sway radius, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes closed and with a concurrent cognitive task. Higher values indicate poorer postural stability.
Time frame: From baseline to the end of treatment at 7 weeks