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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started May 2026
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
May 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
April 13, 2026
April 1, 2026
3 months
January 2, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (9)
Grooved pegboard test
From enrollment to the end of treatment at 7 weeks
Path Length With Eyes Open Without Cognitive Task
From baseline to the end of treatment at 7 weeks
Path Length With Eyes Closed Without Cognitive Task
From baseline to the end of treatment at 7 weeks
Path Length With Eyes Open With Cognitive Task
From baseline to the end of treatment at 7 weeks
Path Length With Eyes Closed Witht Cognitive Task
From baseline to the end of treatment at 7 weeks
- +4 more secondary outcomes
Study Arms (4)
realtDCS&exercise Group
EXPERIMENTAL24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
shamtDCS&exercise Group
PLACEBO COMPARATOR24 sessions of reactive exercise simulatenously with sham tDCS over the motor cortex contralteral to the most affected side.
Exercise Group
ACTIVE COMPARATOR24 sessions of reactive exercise.
Control Group
NO INTERVENTIONNo interventio. Only evaluations before and after 5 weeks time.
Interventions
24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center of Sport Research
Fuenlabrada, Madrid, 28992, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Angel Fernández del Olmo, PhD
Universidad Rey Juan Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 2, 2026
First Posted
April 13, 2026
Study Start
May 10, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.