NCT03485066

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

April 28, 2017

Last Update Submit

September 19, 2019

Conditions

Outcome Measures

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)

    4 weeks

Secondary Outcomes (1)

  • Cognitive performance

    4 weeks

Study Arms (2)

Training

EXPERIMENTAL

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

Behavioral: Tetris

Control

NO INTERVENTION

20 healthy participants, no training between PET/MR measurements

Interventions

TetrisBEHAVIORAL

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

Training

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, Austria

RECRUITING

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Rupert Lanzenberger, Assoc Prof

    Department of Psychiatry and Psychotherapy, Medical University of Vienna

    STUDY DIRECTOR

Central Study Contacts

Rupert Lanzenberger, Assoc Prof

CONTACT

Andreas Hahn, Ass Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof. PD MD, Head of Neuroimaging Labs

Study Record Dates

First Submitted

April 28, 2017

First Posted

April 2, 2018

Study Start

May 1, 2017

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations