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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson' Disease
• Intervention / Treatment: Other: real tDCS and exercise; Other: Sham tDCS and exercise; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Villamil Cabell, PhD; Phone Number: +34 666 66 81 05; Email: eduardo.villamil@urjc.es

Study Locations

• Spain
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28992
      • Recruiting
      • Center of Sport Research
      • Contact: Miguel Angel Fernández del Olmo, PhD; Phone Number: 600077866; Email: miguel.delolmo@urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: realtDCS&exercise Group; 24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.	Other: real tDCS and exercise; 24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
Placebo Comparator: shamtDCS&exercise Group; 24 sessions of reactive exercise simulatenously with sham tDCS over the motor cortex contralteral to the most affected side.	Other: Sham tDCS and exercise; 24 sessions of reactive exercise with sham tDCS
Active Comparator: Exercise Group; 24 sessions of reactive exercise.	Other: Exercise; 24 sessions of reactive exercise
No Intervention: Control Group; No interventio. Only evaluations before and after 5 weeks time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed at Preferred Speed	Gait speed assessed during walking at preferred speed using the OptoGait System. Units m/s	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	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	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	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	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	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.	From enrollment to the end of treatment at 7 weeks
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.	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.	From enrollment to the end of treatment at 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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.	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.	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.	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.	From baseline to the end of treatment at 7 weeks

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Miguel Angel Fernández del Olmo, PhD, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; cortical excitability; exercises training; transcranial direct electrical stimulation; cue training
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: PID2022-139930NB-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No