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 | Active Not Recruiting

• 1 other identifier: 2024-A02141-46
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

deep brain stimulation; monoaminergic neurotransmitters; awake surgery; Intracerebral FSCV

Outcome Measures

Primary Outcomes (1)

• Variation in monoaminergic neurotransmitter concentrations

  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

Study Arms (1)

Intracerebral voltammetric recordings

EXPERIMENTAL

Behavioral: Cognitive tasks

Interventions

Cognitive tasks BEHAVIORAL

Cognitive tasks performed during intracerebral voltammetric recordings

Intracerebral voltammetric recordings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences

Paris, France

Location

Related Publications (32)

• Mosher CP, Mamelak AN, Malekmohammadi M, Pouratian N, Rutishauser U. Distinct roles of dorsal and ventral subthalamic neurons in action selection and cancellation. Neuron. 2021 Mar 3;109(5):869-881.e6. doi: 10.1016/j.neuron.2020.12.025. Epub 2021 Jan 21.

  PMID: 33482087 BACKGROUND

• Hoerl AE, Kennard RW. Ridge Regression: Biased Estimation for Nonorthogonal Problems. Technometrics. 1970;12(1):55-67.

  BACKGROUND

• Tibshirani R. Regression Shrinkage and Selection Via the Lasso. J R Stat Soc Ser B: Stat Methodol. 2018;58(1):267-88.

  BACKGROUND

• Zou H, Hastie T. Regularization and Variable Selection Via the Elastic Net. J R Stat Soc Ser B: Stat Methodol. 2005;67(2):301-20.

  BACKGROUND

• Montague PR, Kishida KT. Computational Underpinnings of Neuromodulation in Humans. Cold Spring Harb Symp Quant Biol. 2018;83:71-82. doi: 10.1101/sqb.2018.83.038166. Epub 2019 Apr 25.

  PMID: 31023828 BACKGROUND

• Gogos AJ, Young JS, Morshed RA, Hervey-Jumper SL, Berger MS. Awake glioma surgery: technical evolution and nuances. J Neurooncol. 2020 May;147(3):515-524. doi: 10.1007/s11060-020-03482-z. Epub 2020 Apr 8.

  PMID: 32270374 BACKGROUND

• Matthews J, Nagao K, Ding C, Newby R, Kempster P, Hohwy J. Raised visual contrast thresholds with intact attention and metacognition in functional motor disorder. Cortex. 2020 Apr;125:161-174. doi: 10.1016/j.cortex.2019.12.009. Epub 2020 Jan 3.

  PMID: 31991241 BACKGROUND

• Huang YT, Georgiev D, Foltynie T, Limousin P, Speekenbrink M, Jahanshahi M. Different effects of dopaminergic medication on perceptual decision-making in Parkinson's disease as a function of task difficulty and speed-accuracy instructions. Neuropsychologia. 2015 Aug;75:577-87. doi: 10.1016/j.neuropsychologia.2015.07.012. Epub 2015 Jul 13.

  PMID: 26184442 BACKGROUND

• Volkow ND, Fowler JS, Gatley SJ, Logan J, Wang GJ, Ding YS, Dewey S. PET evaluation of the dopamine system of the human brain. J Nucl Med. 1996 Jul;37(7):1242-56.

  PMID: 8965206 BACKGROUND

• Ng J, Papandreou A, Heales SJ, Kurian MA. Monoamine neurotransmitter disorders--clinical advances and future perspectives. Nat Rev Neurol. 2015 Oct;11(10):567-84. doi: 10.1038/nrneurol.2015.172. Epub 2015 Sep 22.

  PMID: 26392380 BACKGROUND

• Bergman H. The Hidden Life of the Basal Ganglia: At the Base of Brain and Mind. 2021.

  BACKGROUND

• Tye KM, Deisseroth K. Optogenetic investigation of neural circuits underlying brain disease in animal models. Nat Rev Neurosci. 2012 Mar 20;13(4):251-66. doi: 10.1038/nrn3171.

  PMID: 22430017 BACKGROUND

• Bucher ES, Wightman RM. Electrochemical Analysis of Neurotransmitters. Annu Rev Anal Chem (Palo Alto Calif). 2015;8:239-61. doi: 10.1146/annurev-anchem-071114-040426. Epub 2015 May 4.

  PMID: 25939038 BACKGROUND

• Nutt DJ, Lingford-Hughes A, Erritzoe D, Stokes PR. The dopamine theory of addiction: 40 years of highs and lows. Nat Rev Neurosci. 2015 May;16(5):305-12. doi: 10.1038/nrn3939. Epub 2015 Apr 15.

  PMID: 25873042 BACKGROUND

• Otte C, Gold SM, Penninx BW, Pariante CM, Etkin A, Fava M, Mohr DC, Schatzberg AF. Major depressive disorder. Nat Rev Dis Primers. 2016 Sep 15;2:16065. doi: 10.1038/nrdp.2016.65.

  PMID: 27629598 BACKGROUND

• Craske MG, Stein MB, Eley TC, Milad MR, Holmes A, Rapee RM, Wittchen HU. Anxiety disorders. Nat Rev Dis Primers. 2017 May 4;3:17024. doi: 10.1038/nrdp.2017.24.

  PMID: 28470168 BACKGROUND

• Dayan P. Twenty-five lessons from computational neuromodulation. Neuron. 2012 Oct 4;76(1):240-56. doi: 10.1016/j.neuron.2012.09.027.

  PMID: 23040818 BACKGROUND

• Boureau YL, Dayan P. Opponency revisited: competition and cooperation between dopamine and serotonin. Neuropsychopharmacology. 2011 Jan;36(1):74-97. doi: 10.1038/npp.2010.151. Epub 2010 Sep 29.

  PMID: 20881948 BACKGROUND

• Marder E. Neuromodulation of neuronal circuits: back to the future. Neuron. 2012 Oct 4;76(1):1-11. doi: 10.1016/j.neuron.2012.09.010.

  PMID: 23040802 BACKGROUND

• Kandel ER, Koester JD, Mack SH, Siegelbaum SA. Principles of neural science, 6th ed. Hill MG, editor. 2021.

  BACKGROUND

• Portas CM, Bjorvatn B, Ursin R. Serotonin and the sleep/wake cycle: special emphasis on microdialysis studies. Prog Neurobiol. 2000 Jan;60(1):13-35. doi: 10.1016/s0301-0082(98)00097-5.

  PMID: 10622375 BACKGROUND

• Must A, Juhasz A, Rimanoczy A, Szabo Z, Keri S, Janka Z. Major depressive disorder, serotonin transporter, and personality traits: why patients use suboptimal decision-making strategies? J Affect Disord. 2007 Nov;103(1-3):273-6. doi: 10.1016/j.jad.2007.02.001. Epub 2007 Mar 26.

  PMID: 17382402 BACKGROUND

• Diekhof EK, Falkai P, Gruber O. Functional neuroimaging of reward processing and decision-making: a review of aberrant motivational and affective processing in addiction and mood disorders. Brain Res Rev. 2008 Nov;59(1):164-84. doi: 10.1016/j.brainresrev.2008.07.004. Epub 2008 Jul 21.

  PMID: 18675846 BACKGROUND

• Yildiz O, Smith JR, Purdy RE. Serotonin and vasoconstrictor synergism. Life Sci. 1998;62(19):1723-32. doi: 10.1016/s0024-3205(97)01166-1.

  PMID: 9585103 BACKGROUND

• Goldstein DS. Catecholamines in the periphery. Overview. Adv Pharmacol. 1998;42:529-39. doi: 10.1016/s1054-3589(08)60806-6. No abstract available.

  PMID: 9327957 BACKGROUND

• Moran RJ, Kishida KT, Lohrenz T, Saez I, Laxton AW, Witcher MR, Tatter SB, Ellis TL, Phillips PE, Dayan P, Montague PR. The Protective Action Encoding of Serotonin Transients in the Human Brain. Neuropsychopharmacology. 2018 May;43(6):1425-1435. doi: 10.1038/npp.2017.304. Epub 2018 Jan 3.

  PMID: 29297512 BACKGROUND

• Sands LP, Jiang A, Liebenow B, DiMarco E, Laxton AW, Tatter SB, Montague PR, Kishida KT. Subsecond fluctuations in extracellular dopamine encode reward and punishment prediction errors in humans. Sci Adv. 2023 Dec;9(48):eadi4927. doi: 10.1126/sciadv.adi4927. Epub 2023 Dec 1.

  PMID: 38039368 BACKGROUND

• Kishida KT, Saez I, Lohrenz T, Witcher MR, Laxton AW, Tatter SB, White JP, Ellis TL, Phillips PE, Montague PR. Subsecond dopamine fluctuations in human striatum encode superposed error signals about actual and counterfactual reward. Proc Natl Acad Sci U S A. 2016 Jan 5;113(1):200-5. doi: 10.1073/pnas.1513619112. Epub 2015 Nov 23.

  PMID: 26598677 BACKGROUND

• Kishida KT, Sandberg SG, Lohrenz T, Comair YG, Saez I, Phillips PE, Montague PR. Sub-second dopamine detection in human striatum. PLoS One. 2011;6(8):e23291. doi: 10.1371/journal.pone.0023291. Epub 2011 Aug 4.

  PMID: 21829726 BACKGROUND

• Bang D, Kishida KT, Lohrenz T, White JP, Laxton AW, Tatter SB, Fleming SM, Montague PR. Sub-second Dopamine and Serotonin Signaling in Human Striatum during Perceptual Decision-Making. Neuron. 2020 Dec 9;108(5):999-1010.e6. doi: 10.1016/j.neuron.2020.09.015. Epub 2020 Oct 12.

  PMID: 33049201 BACKGROUND

• Liebenow B, Jiang A, DiMarco E, Wilson T, Siddiqui MS, Ul Haq I, Laxton AW, Tatter SB, Kishida KT. Intracranial subsecond dopamine measurements during a "sure bet or gamble" decision-making task in patients with alcohol use disorder suggest diminished dopaminergic signals about relief. Neurosurg Focus. 2023 Feb;54(2):E3. doi: 10.3171/2022.11.FOCUS22614.

  PMID: 36724520 BACKGROUND

• Clark JJ, Sandberg SG, Wanat MJ, Gan JO, Horne EA, Hart AS, Akers CA, Parker JG, Willuhn I, Martinez V, Evans SB, Stella N, Phillips PE. Chronic microsensors for longitudinal, subsecond dopamine detection in behaving animals. Nat Methods. 2010 Feb;7(2):126-9. doi: 10.1038/nmeth.1412. Epub 2009 Dec 27.

  PMID: 20037591 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): June 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

FR (1)