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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Stress Response

Clinical Trial Details

NCT number	NCT05825677
Study type	Interventional
Source	Hôpital le Vinatier
Contact	Frédéric HAESEBAERT, MD - PhD
Phone	0033437915565
Email	Frederic.HAESEBAERT@ch-le-vinatier.fr
Status	Recruiting
Phase	N/A
Start date	April 11, 2023
Completion date	April 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04544163` - Magnesium Versus High Dose Fentanyl in Endotracheal Intubation	N/A
Recruiting	`NCT06097182` - Postbiotic Intervention for Acute Stress Management	N/A
Completed	`NCT06169475` - Effect of Dexmedetomidine vs Esmolol or Placebo on Cerebral Hemodynamics in Septic Shock	N/A
Recruiting	`NCT06166186` - Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy	N/A
Completed	`NCT02917018` - Effect of Dexmedetomidine on Stress Response and Emergence Agitation During Laparoscopic Surgery	Phase 2/Phase 3
Completed	`NCT01128088` - The Stress Response in Laparoscopic Colorectal Surgery and Its Role in the Development of the Enhanced Recovery Program.	N/A
Completed	`NCT03288610` - Prediction of Inflammatory Response and Hypotensive Syndrome After Cardiac Surgery by Preoperative Copeptin Level	N/A
Completed	`NCT03378674` - Remifentanil and Stress Hormones Response	N/A
Recruiting	`NCT06066619` - Can Cranberry Juice Enhance the Cognition Accuracy and Alleviate Negative Mental Consequences During Multitasking?	N/A
Completed	`NCT05633173` - Effects of Erector Spinae Plane and Caudal Block on Postoperative Stress Response	N/A
Completed	`NCT01717222` - Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy	Phase 4
Completed	`NCT05865509` - Comparison of the Escape Room and Storytelling Methods in Learning the Stress Response	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms