CClinicalTrials.gg
Status unknownNCT03485066Updated Sep 23, 2019

Simultaneous PET/MR Imaging of Human Brain Plasticity

An interventional study of Tetris in Neuronal Plasticity, sponsored by Rupert Lanzenberger. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by Rupert Lanzenberger · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 30 Years
Sex
All
01

Study summary

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.

Read the detailed description

Methodological details: Each subject will undergo two PET/MR examinations. Imaging will include PET as well as acquisition of structural and functional MRI. Task-specific glucose metabolism will be quantified with the radioligand [18F]FDG. Gray matter volume and white matter microstructure will be assessed with T1-weighted and diffusion weighted MRI, respectively. Functional imaging will focus on functional connectivity during rest and task as well as cerebral blood flow as acquired with ASL.

02

Conditions studied

  • Neuronal Plasticity
03

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age range 21-30 years
  • Right-handedness
  • Willingness and competence to sign the informed consent form

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Training

    20 healthy participants, 4 week training of a challenging cognitive task (Tetris) between PET/MR measurements

    Behavioral: Tetris

  • No intervention
    Control

    20 healthy participants, no training between PET/MR measurements

Interventions

  • BehavioralTetris

    The video game Tetris is a cognitively challenging task, which requires mental rotation, problem solving and fast visuo-spatial and motor coordination.

05

What researchers measure

Primary outcomes

  1. Training induced changes in imaging parameters

    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)

    Time frame: 4 weeks

Secondary outcomes

  1. Cognitive performance

    Training induced changes in performance of the video game (score per minute)

    Time frame: 4 weeks

06

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry and Psychotherapy, Medical University of Vienna
    Vienna, Austria
    Recruiting
07

References and documents

Publications

  • Hahn A, Breakspear M, Rischka L, Wadsak W, Godbersen GM, Pichler V, Michenthaler P, Vanicek T, Hacker M, Kasper S, Lanzenberger R, Cocchi L. Reconfiguration of functional brain networks and metabolic cost converge during task performance. Elife. 2020 Apr 21;9:e52443. doi: 10.7554/eLife.52443. PubMed 32314956 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03485066
Lead sponsor
Rupert Lanzenberger
Responsible party
Rupert Lanzenberger (Assoc.Prof. PD MD, Head of Neuroimaging Labs, Medical University of Vienna) — Sponsor-investigator
First posted
Apr 2, 2018
Start date
May 1, 2017
Primary completion
Nov 1, 2020 (estimated)
Completion
Nov 1, 2020 (estimated)
Last update
Sep 23, 2019

Study contacts

Rupert Lanzenberger, Assoc Prof
Contact
rupert.lanzenberger@meduniwien.ac.at
+43140400 ext. 35760
Andreas Hahn, Ass Prof
Contact
+43140400 ext. 23200
Rupert Lanzenberger, Assoc Prof
study director · Department of Psychiatry and Psychotherapy, Medical University of Vienna

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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