- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06243783
Impact of Stress on Brain Energy Metabolism
Impact of Acute Stress and Its Habituation on Brain Energy Metabolism
Background: Stress plays an essential role in the pathophysiology of mental disorders. However, individual differences in the vulnerability to acute and repeated stress are not well understood.
Aim: This work aims to investigate individual differences in glucose metabolism and directional connectivity regulating the neuronal stress response.
Design: 68 healthy volunteers will undergo two simultaneous PET/MRI measurements one week apart. Participants will complete the Montreal Imaging Stress Test during each measurement and in-between. Effects of stress on cognitive performance will be assessed using the n-back working memory task. Individual cortisol levels will be acquired to identify stress (non)responders as well as (non)habituators.
Implications: This work will characterize differences between stress responders vs. non-responders and stress habituators vs. non-habituators in terms of energy metabolism and network connectivity. This individual difference in the stress response may represent an important cornerstone for future evaluation of patients with mental disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andreas Hahn, Assoc.Prof.
- Phone Number: 23200 +43140400
- Email: andreas.hahn@meduniwien.ac.at
Study Contact Backup
- Name: Rupert Lanzenberger, Prof.
- Phone Number: 35760 +43140400
- Email: rupert.lanzenberger@meduniwien.ac.at
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-40 years
- right-handedness
- willingness and competence to sign the informed consent form
Exclusion Criteria:
- History of or current physical, neurological or psychiatric disorder
- History of or current substance abuse or medication, including antipsychotic, antidepressant and antianxiety agents
- Pregnancy of current breast-feeding
- Contraindications for MRI-scanning (e.g., metal implants, steel grafts, etc.), including dental implants causing signal artifacts
- For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection Accordingly, body weight > 105 kg is an exclusion criterion.
- Failure to comply with the study protocol or to follow the instructions of the investigating team.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stress
Montreal Imaging Stress Test during each PET/MRI measurement and in-between
|
In the Montreal Imaging Stress Test, participants are required to solve basic mathematical tasks, but the allowed reaction time is set lower than their average.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress induced changes in glucose metabolism
Time Frame: 1 week
|
Glucose metabolism will be quantified from [18F]FDG PET imaging.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress induced changes in directional connectivity
Time Frame: 1 week
|
Directional connectivity will be computed as combination of MRI-based functional connectivity and glucose metabolism.
|
1 week
|
Stress induced changes in cognitive performance
Time Frame: 1 week
|
Cognitive performance will be obtained by the n-back working memory task.
|
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Hahn, Assoc.Prof., Department of Psychiatry and Psychtherapy, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSY-NIL-0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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