Parkinson DiseaseSTAR-PARKNCT04897633
Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients
A study testing transcranial electric stimulation in people with Parkinson Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- transcranial electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age> = 18 years old
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- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Parkinson Disease
- Being tested
- transcranial electric stimulation
- Keywords
- transcranial stimulation, tDCS, simon task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electric stimulationDevice
Also called DC STIMULATOR PLUS
Simon's task assessment when under tDCS
| Study group | Role | What they receive |
|---|---|---|
| Patients ON | Experimental | Patients will performed Simon's task with tDCS active or sham when treatment is OFF (for standard care procedure) Receives: Device: transcranial electric stimulation |
| Patients OFF | Experimental | Patients will performed Simon's task with tDCS active or sham when treatment is ON (for standard care procedure) Receives: Device: transcranial electric stimulation |
| Healthy volunteers | Experimental | Healthy volunteers will performed Simon's task with tDCS active or sham Receives: Device: transcranial electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid error rate.
Responses recorded on the opposite side to that expected
Measured: Day 2
Rapid error rate.
Responses recorded on the opposite side to that expected
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start2 Jun 2021
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier ARNAUD, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897633
- Sponsor's protocol ID
- 2019-46
- Other IDs
- ID-RCB
- Acronym
- STAR-PARK
- Status last verified
- Jun 2025
- First submitted
- 18 May 2021
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT04897633
- Acronym / sponsor ID
- STAR-PARK / 2019-46
- Conditions
- Parkinson Disease
- Keywords
- transcranial stimulation, tDCS, simon task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients ON | Experimental | Device: transcranial electric stimulationPatients will performed Simon's task with tDCS active or sham when treatment is OFF (for standard care procedure) |
| Patients OFF | Experimental | Device: transcranial electric stimulationPatients will performed Simon's task with tDCS active or sham when treatment is ON (for standard care procedure) |
| Healthy volunteers | Experimental | Device: transcranial electric stimulationHealthy volunteers will performed Simon's task with tDCS active or sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial electric stimulationAlso: DC STIMULATOR PLUSSimon's task assessment when under tDCS | Device | Healthy volunteers, Patients OFF, Patients ON |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Olivier ARNAUD study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electric stimulation in people with Parkinson Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid error rate. (time frame: Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.