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

NCT ID: NCT05825677

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-10-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In a randomized controlled double-blind study, 30 healthy subjects, will be randomly assigned to 2 groups. A group of 15 participants will receive 30 minutes of active tDCS (1mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC); a group of 15 participants will receive 30 minutes of placebo stimulation. All participant will be in a PET-MRI scanner for 110min, during which they will undergo the stimulation (either active or sham). During this stimulation session, all participants will undergo a standardized stress test combining psychosocial stress and physical stress.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The subject will be blind of the treatment he receives (active or placebo). The experimenter, caregiver and investigator will also be blinded from stimulation (active or placebo).

Each subject will be assigned a randomization code, corresponding to the code to enter the tDCS device. This system allows the person who administers tDCS and the subject receiving the stimulation to be blind.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active tDCS

Active brain stimulation Direct current stimulation of DLPFC for 30min with an intensity of 1mA

Group Type ACTIVE_COMPARATOR

tDCS actif

Intervention Type DEVICE

Active brain stimulation

Sham tDCS

Sham brain stimulation Direct current stimulation of DLPFC for 30sec with an intensity of 1mA

Group Type SHAM_COMPARATOR

tDCS Sham

Intervention Type DEVICE

Sham brain stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tDCS actif

Active brain stimulation

Intervention Type DEVICE

tDCS Sham

Sham brain stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jérôme BRUNELIN, PhD

Role: STUDY_DIRECTOR

Vinatier Hospital PsyR2 Team

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-A00907-36

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Role of Brain Dopamine in Chronic Pain
NCT05285683 RECRUITING PHASE2
Cerebral Blood Flow and tDCS
NCT04033133 COMPLETED NA