Understanding the Role of Monoaminergic Neurotransmitters in Cognitive Functions Using Fast-cyclic Voltammetry in Patients with Neurological and Psychiatric Diseases Eligible for Neurosurgical Treatment (COGAMINE) (COGAMINE)

March 3, 2025 updated by: Centre Hospitalier St Anne
This study aims at dynamically mapping local variations in the concentrations of monoaminergic neurotransmitters (for e.g. dopamine, serotonin and noradrenaline) in the human brain using fast-scan cyclic voltammetric recordings (FSCV). This study will be carried out on patients with neurological (for e.g. brain cancer, Parkinson disease (PD) or treatment-resistant epilepsy …) or psychiatric (for e.g. Treatment resistant obsessive compulsive disorder, depression, Tourette syndrome …) diseases who are eligible to neurosurgical treatment. Typical neurosurgical treatments non-exhaustively include: (1) deep brain stimulation (DBS) electrode implanted as part of the routine management of their pathology (PD, etc.) or as part of clinical trials (treatment resistant depression, resistant obsessive-compulsive disorder, etc.), as well as on patients whose pathology requires invasive exploration by stereotactic-electroencephalography (S-EEG) for therapeutic purposes, either as part of their routine management or as part of a clinical trial. The aim of this mapping is to assess fluctuations in local concentrations of key monoaminergic neurotransmitters involved in cognitive functions at an individual level, with a high temporal (sub-second) and spatial resolution, as well as a sensitivity, that was previously unattainable with other neuroimaging techniques. The data collected in this study will improve our understanding of the role of monoaminergic neurotransmitters in normal human cognition, as well as their dysfunctions in psychiatric and neurological disorders. These data may guide research into new therapeutic targets for the treatment of these pathologies. This study requires a large cohort of patients to build up the most comprehensive database possible, for which access to the information collected is essential.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient of 18 years old or older;
  • Patient undergoing S-EEG invasive exploration OR a neurosurgical procedure (such as DBS or resection neurosurgery in an awake patient) as part of the management of a neurological or psychiatric disease (routine management or participation in a clinical study);
  • Patient informed and having signed the consent form;
  • Patient able to perform the cognitive tasks proposed.

Exclusion Criteria:

  • Patient not affiliated to a social security or other social protection scheme;
  • Patient with contraindication to S-EEG or neurosurgery.

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracerebral voltammetric recordings
Behavioral: Cognitive tasks
Cognitive tasks performed during intracerebral voltammetric recordings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in monoaminergic neurotransmitter concentrations
Time Frame: Day 0 to Month 2
Variation in monoaminergic neurotransmitter concentrations as collected using FSCV during the performance of cognitive tasks in different neuropsychiatric or neuro-oncological pathologies.
Day 0 to Month 2

Collaborators and Investigators

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

Sponsor

Centre Hospitalier St Anne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 20, 2025

Primary Completion (Estimated)

June 1, 2035

Study Completion (Estimated)

June 1, 2035

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02141-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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