Effects of Physical Exercise Combined With Transcranial Direct Current Stimulation in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: real tDCS and exercise, Sham tDCS and exercise, Exercise.
- Who it may be relevant to
- Registry conditions: Parkinson' Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of the Combination of Physical Exercise and Transcranial Direct Current Stimulation on Motor Function and Underlying Neurophysiological Mechanisms in Parkinson's Disease
Overview
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.
Detailed description
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.
Interventions
- Other real tDCS and exercise
24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side. - Other Sham tDCS and exercise
24 sessions of reactive exercise with sham tDCS - Other Exercise
24 sessions of reactive exercise
Primary outcome measures
- Gait Speed at Preferred Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Step length at Preferred Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Cadence at Preferred Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Gait Speed at Maximal Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Step Length at Maximal Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Cadence at Maximal Speed [Time frame: From enrollment to the end of treatment at 7 weeks]
- Timed Up and Go test performance [Time frame: From enrollment to the end of treatment at 7 weeks]
- Choice stepping reaction time [Time frame: From enrollment to the end of treatment at 7 weeks]
- Choice arm reaching reaction time [Time frame: From enrollment to the end of treatment at 7 weeks]
Secondary outcome measures (9)
- Grooved pegboard test [Time frame: From enrollment to the end of treatment at 7 weeks]
- Path Length With Eyes Open Without Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Path Length With Eyes Closed Without Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Path Length With Eyes Open With Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Path Length With Eyes Closed Witht Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Sway Radius With Eyes Open Without Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Sway Radius With Eyes Closed Without Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Sway Radius With Eyes Open With Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
- Sway Radius With Eyes Closed With Cognitive Task [Time frame: From baseline to the end of treatment at 7 weeks]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Center of Sport Research — Fuenlabrada
Identifiers
NCT: NCT07524400 · PID2022-139930NB-I00