Impact of Stress on Brain Energy Metabolism | NCT06243783

Studies
Impact of Stress on Brain Energy Metabolism

NCT06243783

Sponsor

Rupert Lanzenberger

Status

Recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

Stress

Interventions

Montreal Imaging Stress Test

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Feb 29, 2028Estimated

Completion Date

Feb 29, 2028Estimated

First Submitted Date

Jan 29, 2024

First Submission Date that Met QC Criteria

Jan 29, 2024

First Posted Date

Feb 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Name	Class
University of Konstanz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Methodological details: Each participant will undergo two PET/MRI scans. Imaging will include functional PET and as well as structural and functional MRI. Stress-specific glucose metabolism will be quantified with the radioligand [18F]FDG. Functional connectivity will be combined with glucose metabolism to assess directional connectivity. Based on previous literature, changes are expected to occur in the anterior cingulate cortex.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress	Experimental	Montreal Imaging Stress Test during each PET/MRI measurement and in-between	Behavioral: Montreal Imaging Stress Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montreal Imaging Stress Test	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress induced changes in glucose metabolism	Glucose metabolism will be quantified from [18F]FDG PET imaging.	1 week

Secondary Outcomes

Measure	Description	Time Frame
Stress induced changes in directional connectivity	Directional connectivity will be computed as combination of MRI-based functional connectivity and glucose metabolism.	1 week
Stress induced changes in cognitive performance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Hahn, Assoc.Prof.	Contact	+43140400	23200	andreas.hahn@meduniwien.ac.at
Rupert Lanzenberger, Prof.	Contact	+43140400	35760	rupert.lanzenberger@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Andreas Hahn, Assoc.Prof.	Department of Psychiatry and Psychtherapy, Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Psychotherapy, Medical University of Vienna	Recruiting	Vienna			Austria

References Module

Citations

Not provided