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Completed

NCT Number: NCT05825677

Investigating Stress-Induced Dopamine Release: a fMRI-PET Study

The stress response is mediated by the activation of the hypothalamo-pituitary-adrenal axis and the sympathetic nervous system, leading to glucocorticoid and catecholamines release respectively. This stress response is regulated by feedback loops, involving cortical and subcortical structures.

Non-invasive brain stimulation applied over the dorsolateral prefrontal cortex modulates the subcortical dopaminergic transmission at rest and can reduce the hormonal and cognitive alterations induced by stress. This study aims to investigate the Non-invasive brain stimulation -induced modulation of dopamine transmission in an acute stress situation.

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Key information

Conditions

Stress Response Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

About this study

Objective: to investigate the influence of Dorsolateral Prefrontal Cortex stimulation during acute stress on the subcortical dopamine transmission in healthy subjects.

Method: 30 healthy subjects will be enrolled and randomized into 2 parallel groups. 15 participants will receive active Transcranial direct current stimulation , the other 15 participants will receive sham Transcranial direct current stimulation.

Transcranial direct current stimulation procedure: active Transcranial direct current stimulation corresponds to 30min of stimulation at 1mA intensity . The sham stimulation corresponds to 30s of real stimulation.

Stress paradigm: In order to induce moderate stress in humans in laboratory condition, the investigators will use the Maastricht Acute Stress test . This test is a combination between physical, hand immersion in cold water and cognitive calculation stress. The test will start 5 minutes after the beginning of stimulation session.

Stress measures: the stress response will be evaluated at the following levels:

  • Neurochemical level: dopamine transmission measured with positron emission tomography
  • Functional brain connectivity: resting-state networks measured with functional magnetic resonance imaging
  • Hormonal level: adrenocorticotropic hormone and cortisol levels measured with blood samples
  • Cognitive level: decision-making and memory assessed with delay-discounting task and reality-monitoring task, respectively
  • Molecular level: expression of genes involved in the glucocorticoid receptor signaling pathway measured through blood samples Exploratory measure: Brain-Derived Neurotrophic Factor and cytoplasmic catechol-O-methyltransferase polymorphisms of participants involved in differential Transcranial direct current stimulation response will be assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • - Men and women aged between 18- and 30-year-old
  • Non-smoker
  • Non-psychotropic user

Exclusion criteria

  • - Have a psychiatric or somatic disorder
  • Have a first-degree family history of a psychiatric disorder
  • Pregnant or nursing women
  • Be on medication, with the exception of oral contraceptives
  • Contraindications to tDCS or MRI examination
  • Participants with pacemaker or cardiac or cerebral implant

Treatment and study plan

tDCS actif

Device

Active brain stimulation

tDCS sham

Device

Sham brain stimulation

Primary outcomes

  1. Dopamine transmission measured with positron emission tomography

    Time frame: One year

    Subcortical dopaminergic transmission will be analyzed, using [11C]raclopride PET activity (D2 receptor antagonist)

Secondary outcomes

  1. Functional brain connectivity

    Time frame: One year

    Resting-state functional connectivity

  2. Hormonal stress reactivity

    Time frame: One year

    ACTH level will be measured

  3. Cognitive stress reactivity

    Time frame: One year

    Decision-making capacities will be measured using a computerized version of the DDT in which participants have to choose between 2 rewards. Memory capacities will be measured using a computerized task evaluating reality-memory.

  4. Expression of genes involved in the glucocorticoid receptor signaling pathway measured through blood samples

    Time frame: One year

    Expression rates of genes involved in the glucocorticoid receptor signaling pathway

  5. Assessment of brain-derived neurotrophic factor before and after transcranial direct current stimulation.

    Time frame: One year

    Exploratory measure: brain-derived neurotrophic factor polymorphisms of participants, involved in differential Transcranial direct current stimulation response, will be assess.

  6. Hormonal stress reactivity

    Time frame: One year

    Cortisol level will be measured

  7. Assessment of Cytoplasmic catechol-O-methyltransferase polymorphisms before and after transcranial direct current stimulation.

    Time frame: One year

    Exploratory measure: Cytoplasmic catechol-O-methyltransferase polymorphisms of participants, involved in differential Transcranial direct current stimulation response, will be assess.

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Acronym: ISIDORE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Mar 6, 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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