Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients (STAR-PARK)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial electric stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring transcranial stimulation, tDCS, simon task
Eligibility Criteria
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).
Sites / Locations
- Service Neurologie et pathologies du mouvementRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patients ON
Patients OFF
Healthy volunteers
Arm Description
Patients will performed Simon's task with tDCS active or sham when treatment is OFF (for standard care procedure)
Patients will performed Simon's task with tDCS active or sham when treatment is ON (for standard care procedure)
Healthy volunteers will performed Simon's task with tDCS active or sham
Outcomes
Primary Outcome Measures
Rapid error rate.
Responses recorded on the opposite side to that expected
Rapid error rate.
Responses recorded on the opposite side to that expected
Secondary Outcome Measures
Full Information
NCT ID
NCT04897633
First Posted
May 18, 2021
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04897633
Brief Title
Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients
Acronym
STAR-PARK
Official Title
Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
transcranial stimulation, tDCS, simon task
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients ON
Arm Type
Experimental
Arm Description
Patients will performed Simon's task with tDCS active or sham when treatment is OFF (for standard care procedure)
Arm Title
Patients OFF
Arm Type
Experimental
Arm Description
Patients will performed Simon's task with tDCS active or sham when treatment is ON (for standard care procedure)
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers will performed Simon's task with tDCS active or sham
Intervention Type
Device
Intervention Name(s)
transcranial electric stimulation
Other Intervention Name(s)
DC STIMULATOR PLUS
Intervention Description
Simon's task assessment when under tDCS
Primary Outcome Measure Information:
Title
Rapid error rate.
Description
Responses recorded on the opposite side to that expected
Time Frame
Day 2
Title
Rapid error rate.
Description
Responses recorded on the opposite side to that expected
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederique Fluchere, MD
Phone
0491389368
Ext
33
Email
frederique.fluchere@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Olivier ARNAUD
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Service Neurologie et pathologies du mouvement
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédérique Fluchère
Email
frederique.fluchere@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients
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