- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485066
Simultaneous PET/MR Imaging of Human Brain Plasticity
Multimodal Associations of Human Brain Plasticity Investigated With Simultaneous PET/MR Imaging
Background: Neuronal plasticity is the brain's ability to continuously adapt to experiences and learning of new skills. Although this affects multiple characteristics of the brain such as structure, function and metabolism, direct interactions between these aspects are largely missing.
Aim: Using recent advancements in neuroimaging we aim to identify novel relationships how neuronal plasticity is related across these characteristics.
Design: 40 healthy subjects will undergo two simultaneous PET/MR measurements at baseline and after 4 weeks. During the measurements a cognitively challenging task will be performed and the training group (20 subjects) will practice during the 4-week period.
Implications: We combine simultaneous PET/MR and novel task-specific PET imaging to study brain metabolism, structure and function in a single measurement session. This provides optimal sensitivity for assessment of multimodal neuroplasticity associations. Knowledge how cognitive training affects multiple characteristics of the brain will also increase our understanding of disorders like depression, dementia and brain injuries, since these are diagnosed with cognitive evaluations. Considering the vast usage of the applied imaging procedures in diagnosis and therapy monitoring, the thorough investigation of multimodal associations offers benefit for the interpretability of neuroimaging in clinical routine.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Vienna, Austria
- Recruiting
- Department of Psychiatry and Psychotherapy, Medical University of Vienna
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Contact:
- Rupert Lanzenberger, Assoc Prof
- Phone Number: 35760 +43140400
- Email: rupert.lanzenberger@meduniwien.ac.at
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Principal Investigator:
- Andreas Hahn, Ass Prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range 21-30 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 or current breastfeeding
- 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 30mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection
- Regular players of the video game Tetris (3 years before scanning).
- 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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Training
20 healthy participants, 4 week training of a challenging cognitive task (Tetris) between PET/MR measurements
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The video game Tetris is a cognitively challenging task, which requires mental rotation, problem solving and fast visuo-spatial and motor coordination.
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NO_INTERVENTION: Control
20 healthy participants, no training between PET/MR measurements
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training induced changes in imaging parameters
Time Frame: 4 weeks
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Imaging parameters are glucose metabolism ([18F]FDG PET), cerebral blood flow (arterial spin labeling MRI), functional connectivity (resting-state and task fMRI), gray matter volume (T1-weighted MRI) and white matter structure (diffusion weighted MRI)
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance
Time Frame: 4 weeks
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Training induced changes in performance of the video game (score per minute)
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rupert Lanzenberger, Assoc Prof, Department of Psychiatry and Psychotherapy, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSY-NIL-0005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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