Parkinson' Disease
Conditions
Keywords
exercises training, transcranial direct electrical stimulation, cue training, cortical excitability, Transcranial Magnetic Stimulation
Brief summary
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
OTHERreal tDCS and exercise
24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
OTHERSham tDCS and exercise
24 sessions of reactive exercise with sham tDCS
OTHERExercise
24 sessions of reactive exercise
Sponsors
Universidad Rey Juan Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This is a blinded, randomized and controlled study. All patients will complete a total of 24 sessions that constitute the physical exercise program with sensory signals. Before and after finishing the 24 clinical, motor and neurophysiological assessments will be carried out. The patients will be distributed into 4 groups of 25 patients corresponding to the 4 intervention modalities: * realtDCS&Exerc Group: real tDCS is applied simultaneously to exercise during the 24 sessions of the program. * shamtDCS&Exer Group: sham tDCS is applied simultaneously to exercise during the 24 sessions of the program. * Exerc Group: 24 sessions of exercise withouth tDCS * Control Group: No exercise, no tDCS, just evaluation before and after a period of 5 weeks.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed at Preferred Speed | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grooved pegboard test | From enrollment to the end of treatment at 7 weeks | 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. |
| Path Length With Eyes Open Without Cognitive Task | From baseline to the end of treatment at 7 weeks | 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 |
| Path Length With Eyes Closed Without Cognitive Task | From baseline to the end of treatment at 7 weeks | 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 |
| Path Length With Eyes Open With Cognitive Task | From baseline to the end of treatment at 7 weeks | 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 |
| Path Length With Eyes Closed Witht Cognitive Task | From baseline to the end of treatment at 7 weeks | 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 |
| Sway Radius With Eyes Open Without Cognitive Task | From baseline to the end of treatment at 7 weeks | 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. |
| Sway Radius With Eyes Closed Without Cognitive Task | From baseline to the end of treatment at 7 weeks | 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. |
| Sway Radius With Eyes Open With Cognitive Task | From baseline to the end of treatment at 7 weeks | 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. |
| Sway Radius With Eyes Closed With Cognitive Task | From baseline to the end of treatment at 7 weeks | 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. |
Countries
Spain
Contacts
CONTACTEduardo Villamil Cabell, PhD
PRINCIPAL_INVESTIGATORMiguel Angel Fernández del Olmo, PhD
Universidad Rey Juan Carlos
Outcome results
None listed