Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients

In Parkinson's disease (PD), recent work has shown that dopaminergic treatments alter one of the two aspects of impulsivity: they do not alter the propensity to produce "automatic" responses, but deteriorate the ability to inhibit and correct (that is, control) them. In healthy subjects, the investigator's team has also demonstrated that transcranial direct current "cathodal" electrical stimulation (tDCS) of Supplementary Motor Areas decreases the frequency of behavioral errors by improving the ability to "correct" responses.

The main objective of this project is to determine whether cathodal tDCS of Supplementary Motor Areas in PD patients under dopaminergic treatment improves the control and correction of errors about to be made and compensates for the deficits induced by the treatment.

All participants will perform a reaction time task of choice (Simon's task), with and without ("sham" session) tDCS. The experimental design of this single-center, single-blind, randomized study will be that of 3 parallel groups (treated Parkinson's disease, untreated Parkinson's disease patient, and matched control subjects) with cross-over application of tDCS. All participants will be blind to the operating mode of the tDCS (either functional or in "sham" mode corresponding to a control condition). The order of the sessions (with and without tDCS) will be randomized within each of the 3 groups of subjects. The analysis of errors about to be made but inhibited in time (known as "early errors") will be carried out through electromyographic (surface) recording of muscle activities involved in motor responses.

tDCS is expected to improve the ability of treated patients to correct their errors about to be made. This study will thus provide a better understanding of the mechanisms of action control and possibly propose a new therapeutic approach for treatment-induced impulsivity disorders in Parkinson's disease.

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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 Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Neurologie et pathologies du mouvement

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Parkinsonien patients:

Age> 18 years old
Idiopathic Parkinson's disease meeting the diagnostic criteria as defined by Ward and Gibb (1990)
Patients usually taking dopaminergic treatment.
No cognitive deterioration with: a Montreal Cognitive Assessment (MoCA) score ≥ 26
Patient with Parkinson's disease in the advanced motor complications stage for which surgical treatment is being considered

Inclusion criteria

for healthy subjects

Age> = 18 years old
Patient free from Idiopathic Parkinson's Disease
No cognitive deterioration: MMSE (MiniMentalSate Evaluation)> 26

Exclusion criteria

for both parkinsonien patients an healthy volunteers:

Uncorrected altered visual acuity
Dyschromatopsia (especially color blindness)
Psychotropic treatment introduced or modified recently (<1 month)
Wearing a pacemaker (Pace Maker or Implantable Defibrillator)
Pregnancy (verified by a urine pregnancy test for women of childbearing age)
Other central nervous system disease (other parkinsonian syndrome, epilesia, stroke, etc.) or peripheral
Intracranial metal implants on the cephalic stage and cochlear implant
Untreated progressive mood or psycho-behavioral disorder
Severe and poorly controlled eczema

Exclusion criteria

for Parkinson's patients only:

Significant and disabling abnormal movement, not allowing good acquisition of the EMG signal (tremors or dyskinesias)
Wearer of a Deep Brain Stimulation device (CI at tDCS).

Treatment and study plan

Transcranial Electric Stimulation

Device

Simon's task assessment when under tDCS

Other names: DC STIMULATOR PLUS

Primary outcomes

Rapid error rate.

Time frame: Day 2

Responses recorded on the opposite side to that expected
Rapid error rate.

Time frame: Day 3

Responses recorded on the opposite side to that expected

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: STAR-PARK

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: May 21, 2021
Registry last updated: Jun 10, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed