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NCT Number: NCT06853977

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive tasks

Behavioral

Cognitive tasks performed during intracerebral voltammetric recordings

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Acronym: COGAMINE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Mar 3, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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