Stress ResponseISIDORENCT05825677
Investigating Stress-Induced Dopamine Release: a fMRI-PET Study
A study testing tDCS actif in people with Stress Response, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Response
- What is being tested?
- tDCS actif
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2023to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Men and women aged between 18- and 30-year-old
- Non-smoker
- Non-psychotropic user
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed 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.
- Conditions
- Stress Response
- Being tested
- tDCS actif, tDCS Sham
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS actifDevice
Active brain stimulation
tDCS ShamDevice
Sham brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active brain stimulation Direct current stimulation of DLPFC for 30min with an intensity of 1mA Receives: Device: tDCS actif |
| Sham tDCS | Sham comparator | Sham brain stimulation Direct current stimulation of DLPFC for 30sec with an intensity of 1mA Receives: Device: tDCS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine transmission measured with positron emission tomography
Subcortical dopaminergic transmission will be analyzed, using [11C]raclopride PET activity (D2 receptor antagonist)
Measured: One year
Secondary outcomes (7)
Functional brain connectivity
Resting-state functional connectivity
Measured: One year
Hormonal stress reactivity
ACTH level will be measured
Measured: One year
Cognitive stress reactivity
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.
Measured: One year
Expression of genes involved in the glucocorticoid receptor signaling pathway measured through blood samples
Expression rates of genes involved in the glucocorticoid receptor signaling pathway
Measured: One year
Assessment of brain-derived neurotrophic factor before and after transcranial direct current stimulation.
Exploratory measure: brain-derived neurotrophic factor polymorphisms of participants, involved in differential Transcranial direct current stimulation response, will be assess.
Measured: One year
Hormonal stress reactivity
Cortisol level will be measured
Measured: One year
Assessment of Cytoplasmic catechol-O-methyltransferase polymorphisms before and after transcranial direct current stimulation.
Exploratory measure: Cytoplasmic catechol-O-methyltransferase polymorphisms of participants, involved in differential Transcranial direct current stimulation response, will be assess.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start11 Apr 2023
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme BRUNELIN, PhD, Study director, Vinatier Hospital PsyR2 Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825677
- Sponsor's protocol ID
- 2022-A00907-36
- Acronym
- ISIDORE
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Stress-Induced Dopamine Release: a fMRI-PET Study
- ClinicalTrials.gov ID
- NCT05825677
- Acronym / sponsor ID
- ISIDORE / 2022-A00907-36
- Conditions
- Stress Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 24 Apr 2023 (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.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCS actifActive brain stimulation Direct current stimulation of DLPFC for 30min with an intensity of 1mA |
| Sham tDCS | Sham comparator | Device: tDCS ShamSham brain stimulation Direct current stimulation of DLPFC for 30sec with an intensity of 1mA |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Men and women aged between 18- and 30-year-old
- Non-smoker
- Non-psychotropic user
Key exclusion criteria (6 listed)
- - 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
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 |
|---|---|---|
| tDCS actifActive brain stimulation | Device | Active tDCS |
| tDCS ShamSham brain stimulation | Device | Sham tDCS |
Primary outcome
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)
7 secondary outcomes
Functional brain connectivity
Time frame: One year
Hormonal stress reactivity
Time frame: One year
Cognitive stress reactivity
Time frame: One year
Expression of genes involved in the glucocorticoid receptor signaling pathway measured through blood samples
Time frame: One year
Assessment of brain-derived neurotrophic factor before and after transcranial direct current stimulation.
Time frame: One year
Hormonal stress reactivity
Time frame: One year
Assessment of Cytoplasmic catechol-O-methyltransferase polymorphisms before and after transcranial direct current stimulation.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Stress Response
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingPhase 4
Beta-Blocker Influences on Inflammatory and Neural Responses to Stress
Cardiovascular Disease
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
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.
Jérôme BRUNELIN, PhD study director
Vinatier Hospital PsyR2 Team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS actif in people with Stress Response, run by Hôpital le Vinatier 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dopamine transmission measured with positron emission tomography (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.