Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition

Parkinson Disease Clinical Trial

— METACTION  

Official title:

Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04461730
• Other study ID #: 38RC19.271
• Secondary ID: 2019-A02328-49
• Status: Withdrawn
• Start date: December 2021
• Est. completion date: November 2025

Study information

• Verified date: April 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• OCD
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral effect of DBS on confidence	Confidence in correct and incorrect responses will be compared on and off stimulation	by fall 2024
Secondary	Effect of DBS on EEG markers of confidence	EEG correlates of confidence in correct and incorrect responses will be compared on and off stimulation	by fall 2024