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)

Not Applicable

Active, not recruiting

• Conditions: Neurological Diseases or Conditions; Psychiatric Diseases; Candidates for Deep Brain Stimulation; Candidates for Invasive S-EEG; Candidates for Awake Surgery

• Registration Number: NCT06853977
• Lead Sponsor: Centre Hospitalier St Anne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-20
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2035-06
• Study Completion: 2035-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation in monoaminergic neurotransmitter concentrations	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.

Trial Locations

Locations (1)

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences; 🇫🇷 Paris, France