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Parkinson' DiseaseExtDCSPARKNCT07524400

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

A study testing real tDCS and exercise and Exercise in people with Parkinson' Disease, run by Universidad Rey Juan Carlos at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Parkinson' Disease
What is being tested?
real tDCS and exercise and Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSpain
Study dates
10 May 2026to 30 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eduardo Villamil Cabell, PhD contact

+34 666 66 81 05

eduardo.villamil@urjc.es

Spain1 site, 1 recruiting
  • Center of Sport Research

    Fuenlabrada, Madrid, 28992

    Miguel Angel Fernández del Olmo, PhD, 600077866, miguel.delolmo@urjc.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
real tDCS and exercise, Sham tDCS and exercise, Exercise
Keywords
exercises training, transcranial direct electrical stimulation, cue training, cortical excitability, Transcranial Magnetic Stimulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • real tDCS and exerciseOther

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

  • Sham tDCS and exerciseOther

    24 sessions of reactive exercise with sham tDCS

  • ExerciseOther

    24 sessions of reactive exercise

Study groups in NCT07524400
Study groupRoleWhat they receive
realtDCS&exercise GroupExperimental24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
Receives: Other: real tDCS and exercise
shamtDCS&exercise GroupPlacebo comparator24 sessions of reactive exercise simulatenously with sham tDCS over the motor cortex contralteral to the most affected side.
Receives: Other: Sham tDCS and exercise
Exercise GroupActive comparator24 sessions of reactive exercise.
Receives: Other: Exercise
Control GroupNo interventionNo interventio. Only evaluations before and after 5 weeks time.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait Speed at Preferred Speed

    Gait speed assessed during walking at preferred speed using the OptoGait System. Units m/s

    Measured: From enrollment to the end of treatment at 7 weeks

  2. Step length at Preferred Speed

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

    Measured: From enrollment to the end of treatment at 7 weeks

  3. Cadence at Preferred Speed

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

    Measured: From enrollment to the end of treatment at 7 weeks

  4. Gait Speed at Maximal Speed

    Gait speed assessed during walking at maximal speed using the OptoGait System. Units m/s

    Measured: From enrollment to the end of treatment at 7 weeks

  5. Step Length at Maximal Speed

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

    Measured: From enrollment to the end of treatment at 7 weeks

  6. Cadence at Maximal Speed

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

    Measured: From enrollment to the end of treatment at 7 weeks

  7. 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.

    Measured: From enrollment to the end of treatment at 7 weeks

  8. 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.

    Measured: From enrollment to the end of treatment at 7 weeks

  9. 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.

    Measured: From enrollment to the end of treatment at 7 weeks

Secondary outcomes (9)
  1. 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.

    Measured: From enrollment to the end of treatment at 7 weeks

  2. 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

    Measured: From baseline to the end of treatment at 7 weeks

  3. 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

    Measured: From baseline to the end of treatment at 7 weeks

  4. 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

    Measured: From baseline to the end of treatment at 7 weeks

  5. 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

    Measured: From baseline to the end of treatment at 7 weeks

  6. 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.

    Measured: From baseline to the end of treatment at 7 weeks

  7. 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.

    Measured: From baseline to the end of treatment at 7 weeks

  8. 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.

    Measured: From baseline to the end of treatment at 7 weeks

  9. 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.

    Measured: From baseline to the end of treatment at 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start10 May 2026 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524400
Sponsor's protocol ID
PID2022-139930NB-I00
Acronym
ExtDCSPARK
Status last verified
Apr 2026
First submitted
2 Jan 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the research team. All analyses will be conducted by the study investigators. The dataset includes detailed neurophysiological, clinical, and kinematic data that could potentially allow participant re-identification. Access to the data will therefore be restricted in accordance with data protection regulations and the informed consent provided by participants.

Questions about this trial

What is this clinical trial studying?

A study testing real tDCS and exercise and Exercise in people with Parkinson' Disease, run by Universidad Rey Juan Carlos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eduardo Villamil Cabell, PhD (+34 666 66 81 05, eduardo.villamil@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed at Preferred Speed (time frame: From enrollment to the end of treatment at 7 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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