Neurological Diseases or ConditionsCOGAMINENCT06853977

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)

A study testing Cognitive tasks in people with Neurological Diseases or Conditions and Psychiatric Diseases, run by Centre Hospitalier St Anne at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurological Diseases or Conditions, Psychiatric Diseases, Candidates for Deep Brain Stimulation
What is being tested?: Cognitive tasks
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteFrance
Study dates: 20 Feb 2025to Jun 2035
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences
Paris

Other trials in France

About this study

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
Being tested: Cognitive tasks
Keywords: deep brain stimulation, monoaminergic neurotransmitters, awake surgery, Intracerebral FSCV
Medical subject headings: Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive tasksBehavioural
Cognitive tasks performed during intracerebral voltammetric recordings

Study groups in NCT06853977
Study group	Role	What they receive
Intracerebral voltammetric recordings	Experimental	Not described Receives: Behavioral: Cognitive tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 to Month 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 2025Jun 2035

First posted3 Mar 2025
Study start20 Feb 2025
Primary completionJun 2035 (estimated)
Study completionJun 2035 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06853977
Sponsor's protocol ID: 2024-A02141-46
Acronym: COGAMINE
Status last verified: Feb 2025
First submitted: 25 Feb 2025
Last updated: 5 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33482087
Hoerl AE, Kennard RW. Ridge Regression: Biased Estimation for Nonorthogonal Problems. Technometrics. 1970;12(1):55-67.
Tibshirani R. Regression Shrinkage and Selection Via the Lasso. J R Stat Soc Ser B: Stat Methodol. 2018;58(1):267-88.
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.
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.
PubMed 31023828
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.
PubMed 32270374
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.
PubMed 31991241
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.
PubMed 26184442
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.
PubMed 8965206
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.
PubMed 26392380
Bergman H. The Hidden Life of the Basal Ganglia: At the Base of Brain and Mind. 2021.
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.
PubMed 22430017
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.
PubMed 25939038
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.
PubMed 25873042
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.
PubMed 27629598

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06853977
Acronym / sponsor ID: COGAMINE / 2024-A02141-46
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
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Centre Hospitalier St AnneUniversity, hospital or other
Study start: 20 Feb 2025 (actual)
Primary completion: Jun 2035 (estimated)
Study completion: Jun 2035 (estimated)
First posted: 3 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intracerebral voltammetric recordings	Experimental	Behavioral: Cognitive tasks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive tasksCognitive tasks performed during intracerebral voltammetric recordings	Behavioural	Intracerebral voltammetric recordings

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Background: PubMed 33482087Mosher 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.
BackgroundHoerl AE, Kennard RW. Ridge Regression: Biased Estimation for Nonorthogonal Problems. Technometrics. 1970;12(1):55-67.
BackgroundTibshirani R. Regression Shrinkage and Selection Via the Lasso. J R Stat Soc Ser B: Stat Methodol. 2018;58(1):267-88.
BackgroundZou 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: PubMed 31023828Montague 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.
Background: PubMed 32270374Gogos 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.
Background: PubMed 31991241Matthews 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.
Background: PubMed 26184442Huang 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.
Background: PubMed 8965206Volkow 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.
Background: PubMed 26392380Ng 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.
BackgroundBergman H. The Hidden Life of the Basal Ganglia: At the Base of Brain and Mind. 2021.
Background: PubMed 22430017Tye 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive tasks in people with Neurological Diseases or Conditions and Psychiatric Diseases, run by Centre Hospitalier St Anne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in monoaminergic neurotransmitter concentrations (time frame: Day 0 to Month 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06853977, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.