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Active, not recruiting Not applicable

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)

NCT06853977 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-02-20
Last updated
2025-03-05

Condition(s) studied

Neurological Diseases or ConditionsPsychiatric DiseasesCandidates for Deep Brain StimulationCandidates for Invasive S-EEGCandidates for Awake Surgery

Investigational drug(s) / intervention(s)

Cognitive tasks

Cognitive tasks: Cognitive tasks performed during intracerebral voltammetric recordings

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06853977 on ClinicalTrials.gov ↗ ← All trials in France