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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04461730
Other study ID # 38RC19.271
Secondary ID 2019-A02328-49
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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