<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04461730</url>
  </required_header>
  <id_info>
    <org_study_id>38RC19.271</org_study_id>
    <secondary_id>2019-A02328-49</secondary_id>
    <nct_id>NCT04461730</nct_id>
  </id_info>
  <brief_title>Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition</brief_title>
  <acronym>METACTION</acronym>
  <official_title>Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The term perceptual awareness refers to subjective experience... or the phenomenology&#xD;
      associated with the processing of a sensory stimulus. The term metacognition refers to our&#xD;
      ability of introspection, knowledge and control of our own cognitive processes. The objective&#xD;
      of this research is to establish the contribution of the basal ganglia and thalamus to the&#xD;
      perceptual awareness and meta-cognition, using deep brain stimulation coupled with&#xD;
      electroencephalography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    team no more available to lead research&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">November 2025</completion_date>
  <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral effect of DBS on confidence</measure>
    <time_frame>by fall 2024</time_frame>
    <description>Confidence in correct and incorrect responses will be compared on and off stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of DBS on EEG markers of confidence</measure>
    <time_frame>by fall 2024</time_frame>
    <description>EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>OCD</condition>
  <condition>Dystonia</condition>
  <arm_group>
    <arm_group_label>Parkinson disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>essential tremor</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>dystonia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>OCD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>deep brain stimulation</intervention_name>
    <description>Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation</description>
    <arm_group_label>OCD</arm_group_label>
    <arm_group_label>Parkinson disease</arm_group_label>
    <arm_group_label>dystonia</arm_group_label>
    <arm_group_label>essential tremor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pathologies included will be Parkinson's disease (PD), essential tremor, dystonia, and&#xD;
        obsessive compulsive disorder (OCD).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient in need of brain stimulation therapy for motor disorders (Parkinson's&#xD;
             disease, tremor, dystonia) or psychiatric disorders (OCD).&#xD;
&#xD;
          -  Outpatient or inpatient follow-up&#xD;
&#xD;
          -  Fluent in French and able to understand the study procedures&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  Patient affiliated to social security&#xD;
&#xD;
          -  Written agreement to participate in the patient's study&#xD;
&#xD;
          -  Intellectual abilities compatible with the performance of cognitive or motor tasks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women,&#xD;
             parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by&#xD;
             judicial or administrative decision, person subject to a legal protection measure&#xD;
&#xD;
          -  Patients in whom transient cessation of stimulation is not tolerated&#xD;
&#xD;
          -  Subject in period of exclusion from another study&#xD;
&#xD;
          -  Subject cannot be contacted in case of emergency&#xD;
&#xD;
          -  Subject under administrative or judicial supervision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ELENA MORO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metacognition</keyword>
  <keyword>consciousness</keyword>
  <keyword>deep brain stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dystonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Experimental paradigms, anonymized behavioral and EEG data and analysis scripts will be made freely available on dedicated platforms (e.g zenodo)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be shared upon publication of results, for an unlimited duration.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461730
org study id: 38RC19.271
secondary id: 2019-A02328-49
nct id: NCT04461730
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Behavioral effect of DBS on confidence
time frame: by fall 2024
description: Confidence in correct and incorrect responses will be compared on and off stimulation
measure: Effect of DBS on EEG markers of confidence
time frame: by fall 2024
description: EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation
arm group label: Parkinson disease
arm group label: essential tremor
arm group label: dystonia
arm group label: OCD
arm group label: healthy volunteers
intervention type: Device
intervention name: deep brain stimulation
description: Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
arm group label: OCD
arm group label: Parkinson disease
arm group label: dystonia
arm group label: essential tremor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ELENA MORO
role: Principal Investigator
affiliation: University Hospital, Grenoble
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dystonia
sharing ipd: Yes
ipd description: Experimental paradigms, anonymized behavioral and EEG data and analysis scripts will be made freely available on dedicated platforms (e.g zenodo)
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: Data will be shared upon publication of results, for an unlimited duration.