Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition

Withdrawn

• Conditions: Dystonia; Parkinson Disease; OCD
• Interventions: Device: deep brain stimulation

• Registration Number: NCT04461730
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-08
• Study Start: 2021-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13
• Primary Completion: 2024-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
essential tremor	deep brain stimulation	-
dystonia	deep brain stimulation	-
Parkinson disease	deep brain stimulation	-
OCD	deep brain stimulation	-

Primary Outcome Measures

Name	Time	Method
Behavioral effect of DBS on confidence	by fall 2024	Confidence in correct and incorrect responses will be compared on and off stimulation

Secondary Outcome Measures

Name	Time	Method
Effect of DBS on EEG markers of confidence	by fall 2024	EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation