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NCT Number: NCT07524400

Effects of Physical Exercise Combined With Transcranial Direct Current Stimulation in Parkinson's Disease

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.

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Key information

Conditions

Parkinson' Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Sport Research

Fuenlabrada, Madrid, 28992, Spain

Location status: Recruiting

Location contact

Miguel Angel Fernández del Olmo, PhD

CONTACT

[email protected]

600077866

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

real tDCS and exercise

Other

24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.

Sham tDCS and exercise

Other

24 sessions of reactive exercise with sham tDCS

Exercise

Other

24 sessions of reactive exercise

Primary outcomes

  1. Gait Speed at Preferred Speed

    Time frame: 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

  2. Step length at Preferred Speed

    Time frame: From enrollment to the end of treatment at 7 weeks

    Step length assessed during walking at preferred speed using the OptoGait System. Units meters

  3. Cadence at Preferred Speed

    Time frame: From enrollment to the end of treatment at 7 weeks

    Cadence assessed during walking at preferred speed using the OptoGait System. Units steps/min

  4. Gait Speed at Maximal Speed

    Time frame: 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

  5. Step Length at Maximal Speed

    Time frame: From enrollment to the end of treatment at 7 weeks

    Step length assessed during walking at maximal speed using the OptoGait System. Units meters

  6. Cadence at Maximal Speed

    Time frame: From enrollment to the end of treatment at 7 weeks

    Cadence assessed during walking at maximal speed using the OptoGait System. Units steps/minute

  7. Timed Up and Go test performance

    Time frame: 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.

  8. Choice stepping reaction time

    Time frame: 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.

  9. Choice arm reaching reaction time

    Time frame: 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 outcomes

  1. Grooved pegboard test

    Time frame: 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.

  2. Path Length With Eyes Open Without Cognitive Task

    Time frame: 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

  3. Path Length With Eyes Closed Without Cognitive Task

    Time frame: 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

  4. Path Length With Eyes Open With Cognitive Task

    Time frame: 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

  5. Path Length With Eyes Closed Witht Cognitive Task

    Time frame: 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

  6. Sway Radius With Eyes Open Without Cognitive Task

    Time frame: 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.

  7. Sway Radius With Eyes Closed Without Cognitive Task

    Time frame: 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.

  8. Sway Radius With Eyes Open With Cognitive Task

    Time frame: 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.

  9. Sway Radius With Eyes Closed With Cognitive Task

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Villamil Cabell, PhD

CONTACT

[email protected]

+34 666 66 81 05

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effects of the Combination of Physical Exercise and Transcranial Direct Current Stimulation on Motor Function and Underlying Neurophysiological Mechanisms in Parkinson's Disease

Acronym: ExtDCSPARK

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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