Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients (STAR-PARK)

June 5, 2025 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Service Neurologie et pathologies du mouvement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients ON
Patients will performed Simon's task with tDCS active or sham when treatment is OFF (for standard care procedure)
Device: transcranial electric stimulation
Simon's task assessment when under tDCS
Other Names:
  • DC STIMULATOR PLUS
Experimental: Patients OFF
Patients will performed Simon's task with tDCS active or sham when treatment is ON (for standard care procedure)
Device: transcranial electric stimulation
Simon's task assessment when under tDCS
Other Names:
  • DC STIMULATOR PLUS
Experimental: Healthy volunteers
Healthy volunteers will performed Simon's task with tDCS active or sham
Device: transcranial electric stimulation
Simon's task assessment when under tDCS
Other Names:
  • DC STIMULATOR PLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid error rate.
Time Frame: Day 2
Responses recorded on the opposite side to that expected
Day 2
Rapid error rate.
Time Frame: Day 3
Responses recorded on the opposite side to that expected
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Jean Olivier ARNAUD, APHM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

January 16, 2025

Study Completion (Actual)

January 16, 2025

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-46
  • ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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