Neuronal PlasticityNCT03485066
Simultaneous PET/MR Imaging of Human Brain Plasticity
A study testing Tetris in people with Neuronal Plasticity, run by Rupert Lanzenberger at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuronal Plasticity
- What is being tested?
- Tetris
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2017to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 21-30 years
- Right-handedness
- Willingness and competence to sign the informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Andreas Hahn, Ass Prof contact
Austria1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna
Rupert Lanzenberger, Assoc Prof, +43140400 ext. 35760, rupert.lanzenberger@meduniwien.ac.at
Andreas Hahn, Ass Prof
About this study
Official title: 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.
Read more
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.
- Conditions
- Neuronal Plasticity
- Being tested
- Tetris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrisBehavioural
The video game Tetris is a cognitively challenging task, which requires mental rotation, problem solving and fast visuo-spatial and motor coordination.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 20 healthy participants, 4 week training of a challenging cognitive task (Tetris) between PET/MR measurements Receives: Behavioral: Tetris |
| Control | No intervention | 20 healthy participants, no training between PET/MR measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (1)
Cognitive performance
Training induced changes in performance of the video game (score per minute)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 May 2017
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuronal PlasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rupert Lanzenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Rupert Lanzenberger, Assoc Prof, Study director, Department of Psychiatry and Psychotherapy, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485066
- Sponsor's protocol ID
- PSY-NIL-0005
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Associations of Human Brain Plasticity Investigated With Simultaneous PET/MR Imaging
- ClinicalTrials.gov ID
- NCT03485066
- Acronym / sponsor ID
- PSY-NIL-0005
- Conditions
- Neuronal Plasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rupert LanzenbergerUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Tetris20 healthy participants, 4 week training of a challenging cognitive task (Tetris) between PET/MR measurements |
| Control | No intervention | –20 healthy participants, no training between PET/MR measurements |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 21-30 years
- Right-handedness
- Willingness and competence to sign the informed consent form
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrisThe video game Tetris is a cognitively challenging task, which requires mental rotation, problem solving and fast visuo-spatial and motor coordination. | Behavioural | Training |
Primary outcome
Training induced changes in imaging parameters
Time frame: 4 weeks
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)
1 secondary outcome
Cognitive performance
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 32314956Hahn 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.
- Neuroimaging Labs, Dept. of Psychiatry and Psychotherapy, Medical University of Vienna, AustriaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Hahn, Ass Prof contact
Rupert Lanzenberger, Assoc Prof study director
Department of Psychiatry and Psychotherapy, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetris in people with Neuronal Plasticity, run by Rupert Lanzenberger at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rupert Lanzenberger, Assoc Prof (+43140400 ext. 35760, rupert.lanzenberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training induced changes in imaging parameters (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.