Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition (METACTION)

April 5, 2022 updated by: University Hospital, Grenoble
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologies included will be Parkinson's disease (PD), essential tremor, dystonia, and obsessive compulsive disorder (OCD).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
OCD
Device: deep brain stimulation
Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
Parkinson disease
Device: deep brain stimulation
Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
essential tremor
Device: deep brain stimulation
Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
dystonia
Device: deep brain stimulation
Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral effect of DBS on confidence
Time Frame: by fall 2024
Confidence in correct and incorrect responses will be compared on and off stimulation
by fall 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of DBS on EEG markers of confidence
Time Frame: by fall 2024
EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation
by fall 2024

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Elena Moro, University Hospital, Grenoble

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 (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.271
  • 2019-A02328-49 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Experimental paradigms, anonymized behavioral and EEG data and analysis scripts will be made freely available on dedicated platforms (e.g zenodo)

IPD Sharing Time Frame

Data will be shared upon publication of results, for an unlimited duration.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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