Parkinson DiseaseMETACTIONNCT04461730
Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition
An observational study of Parkinson Disease and OCD, run by University Hospital, Grenoble.
Trial summary
The term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. The term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. 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, OCD, Dystonia
- What is being tested?
- deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Nov 2025
- Phase
- Observational
- 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
Study population: Pathologies included will be Parkinson's disease (PD), essential tremor, dystonia, and obsessive compulsive disorder (OCD).
Who may be able to join
- Major patient in need of brain stimulation therapy for motor disorders (Parkinson's disease, tremor, dystonia) or psychiatric disorders (OCD).
- Outpatient or inpatient follow-up
- Fluent in French and able to understand the study procedures
- informed consent
- Patient affiliated to social security
- Written agreement to participate in the patient's study
- Intellectual abilities compatible with the performance of cognitive or motor tasks
Who cannot join
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Patients in whom transient cessation of stimulation is not tolerated
- Subject in period of exclusion from another study
- Subject cannot be contacted in case of emergency
- Subject under administrative or judicial supervision
About this study
The term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. The term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. The objective of this research is to establish the contribution of the basal ganglia and thalamus to the perceptual awareness and meta-cognition, using deep brain stimulation coupled with electroencephalography.
- Conditions
- Parkinson Disease, OCD, Dystonia
- Being tested
- deep brain stimulation
- Keywords
- metacognition, consciousness, deep brain stimulation
- Medical subject headings
- Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationDevice
Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease | Not described Receives: Device: deep brain stimulation | |
| essential tremor | Not described Receives: Device: deep brain stimulation | |
| dystonia | Not described Receives: Device: deep brain stimulation | |
| OCD | Not described Receives: Device: deep brain stimulation | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral effect of DBS on confidence
Confidence in correct and incorrect responses will be compared on and off stimulation
Measured: by fall 2024
Secondary outcomes (1)
Effect of DBS on EEG markers of confidence
EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation
Measured: by fall 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study startDec 2021 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: team no more available to lead research
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 University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ELENA MORO, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461730
- Sponsor's protocol ID
- 38RC19.271
- Other IDs
- 2019-A02328-49
- Acronym
- METACTION
- Status last verified
- Apr 2022
- First submitted
- 26 Jun 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Experimental paradigms, anonymized behavioral and EEG data and analysis scripts will be made freely available on dedicated platforms (e.g zenodo)
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition
- ClinicalTrials.gov ID
- NCT04461730
- Acronym / sponsor ID
- METACTION / 38RC19.271
- Conditions
- Parkinson Disease, OCD, Dystonia
- Keywords
- metacognition, consciousness, deep brain stimulation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: team no more available to lead research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Jul 2020 (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.
The term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. The term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. The objective of this research is to establish the contribution of the basal ganglia and thalamus to the perceptual awareness and meta-cognition, using deep brain stimulation coupled with electroencephalography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease | – | Device: deep brain stimulation |
| essential tremor | – | Device: deep brain stimulation |
| dystonia | – | Device: deep brain stimulation |
| OCD | – | Device: deep brain stimulation |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologies included will be Parkinson's disease (PD), essential tremor, dystonia, and obsessive compulsive disorder (OCD).
Key inclusion criteria (7 listed)
- Major patient in need of brain stimulation therapy for motor disorders (Parkinson's disease, tremor, dystonia) or psychiatric disorders (OCD).
- Outpatient or inpatient follow-up
- Fluent in French and able to understand the study procedures
- informed consent
- Patient affiliated to social security
Key exclusion criteria (5 listed)
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Patients in whom transient cessation of stimulation is not tolerated
- Subject in period of exclusion from another study
- Subject cannot be contacted in case of emergency
- Subject under administrative or judicial supervision
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 |
|---|---|---|
| deep brain stimulationBehavioral and electroencephalographic responses will be compared on and off deep brain stimulation | Device | OCD, Parkinson disease, dystonia, essential tremor |
Primary outcome
Behavioral effect of DBS on confidence
Time frame: by fall 2024
Confidence in correct and incorrect responses will be compared on and off stimulation
1 secondary outcome
Effect of DBS on EEG markers of confidence
Time frame: by fall 2024
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Yes. Experimental paradigms, anonymized behavioral and EEG data and analysis scripts will be made freely available on dedicated platforms (e.g zenodo)
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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.
ELENA MORO principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and OCD, run by University Hospital, Grenoble.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Behavioral effect of DBS on confidence (time frame: by fall 2024). 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 13 Apr 2022.