Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition

NCT04461730 | Withdrawn DMC

• 2 other identifiers: 38RC19.2712019-A02328-49
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

metacognition; consciousness; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Behavioral effect of DBS on confidence

  Confidence in correct and incorrect responses will be compared on and off stimulation

  by fall 2024

Secondary Outcomes (1)

• Effect of DBS on EEG markers of confidence

  by fall 2024

Study Arms (5)

Parkinson disease

Device: deep brain stimulation

essential tremor

Device: deep brain stimulation

dystonia

Device: deep brain stimulation

OCD

Device: deep brain stimulation

healthy volunteers

Interventions

deep brain stimulation DEVICE

Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation

OCD; Parkinson disease; dystonia; essential tremor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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 cannot be contacted in case of emergency
• Subject under administrative or judicial supervision

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Parkinson Disease; Dystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• ELENA MORO

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: December 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be shared upon publication of results, for an unlimited duration.