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

NCT05825677 | Completed

• 1 other identifier: 2022-A00907-36
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Response

Outcome Measures

Primary Outcomes (1)

• Dopamine transmission measured with positron emission tomography

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

  One year

Secondary Outcomes (7)

• Functional brain connectivity

  One year

• Hormonal stress reactivity

  One year

• Cognitive stress reactivity

  One year

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

  One year

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

  One year

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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

Device: tDCS actif

Sham tDCS

SHAM COMPARATOR

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

Device: tDCS Sham

Interventions

tDCS actif DEVICE

Active brain stimulation

Active tDCS

tDCS Sham DEVICE

Sham brain stimulation

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jérôme BRUNELIN, PhD

  Vinatier Hospital PsyR2 Team

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: April 11, 2023
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)