SchizophreniaSCZNCT03522220
Augmentation of Neuronal Network Plasticity in Schizophrenia
A study testing 3D navigation video game intervention, video game intervention without 3D navigation and No 3D navigation in people with Schizophrenia and Healthy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Healthy
- What is being tested?
- 3D navigation video game intervention, video game intervention without 3D navigation and No 3D navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2016to 31 Dec 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinically stabilized
- at least one schizophrenic episode in their lives
- International Classification of Diseases 10 (ICD-10) F20.x (and F25)
Who cannot join
- clinically relevant anemia
- MRI contraindication
- earlier electroconvulsive shock treatment
- significant somatic or neurological disease
- significant alcohol or substance abuse in the year before
- more than 1h video games per day more than 6 months before study start
- simultaneous major psychiatric disease (if symptomatic in the foreground)
Trial locations and contacts
1 site in 1 country.
Maxi Becker, MSc contact
Simone Kühn, Prof contact
Germany1 site, 1 recruiting
- Recruiting
University Clinic Hamburg-Eppendorf
Hamburg, 20251
Maxi Becker, MSc., max.becker@uke.de
Simone Kuehn, Prof., s.kuehn@uke.de
About this study
Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.
- Conditions
- Schizophrenia, Healthy
- Being tested
- 3D navigation video game intervention, video game intervention without 3D navigation, No 3D navigation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D navigation video game interventionBehavioural
Participants intensively train with a video game (Super Mario DS)
video game intervention without 3D navigationBehavioural
Participants train with a video game (Super Mario Bros)
No 3D navigationBehavioural
Participants read on a kindle device (control group)
| Study group | Role | What they receive |
|---|---|---|
| 3D Super Mario Game Condition | Experimental | 3D navigation video game intervention Receives: Behavioral: 3D navigation video game intervention |
| 2D Super Mario Game Condition | Active comparator | Video game intervention without 3D navigation Receives: Behavioral: video game intervention without 3D navigation |
| Kindle Device | Active comparator | No 3D navigation Receives: Behavioral: No 3D navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1 - MRI
The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training
Measured: 2 months (= training time and 2 months after training end)
Cognition - Spatial Orientation
The investigators look for changes in cognition specifically regarding spatial orientation (MATRICS, computer tests measuring spatial orientation with and without external cue) due to training.
Measured: 2 months (= training time and 2 months after training end)
Positive & Negative Symptoms in patients
The investigators look for changes in positive and negative symptoms (PANSS) due to training.
Measured: 2 months (= training time and 2 months after training end)
Secondary outcomes (4)
Resting State fMRI
The investigators look for blood oxygen level dependency (BOLD) changes in resting state fMRI specifically in the Hippocampus and Prefrontal Areas due to the training
Measured: 2 months (= training time and 2 months after training end)
Spectroscopy - glutamate
The investigators look for glutamate concentration changes in the hippocampus due to the training
Measured: 2 month (= training time and 2 month after training end)
Diffusion Tensor Imaging (DTI)
The investigators look for structural connectivity changes in DTI images due to the training
Measured: 2 month (= training time and 2 month after training end)
Biomarkers (BDNF & interleukin 1 & 6)
The investigators look for plasticity induced changes in biomarkers (interleukin1 and 6 and BDNF [brain-derived neurotrophic factor]) due to training
Measured: 2 month (= training time and 2 month after training end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Sep 2016
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522220
- Sponsor's protocol ID
- SFB936 C7
- Acronym
- SCZ
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Neuronal Network Plasticity in Schizophrenia
- ClinicalTrials.gov ID
- NCT03522220
- Acronym / sponsor ID
- SCZ / SFB936 C7
- Conditions
- Schizophrenia, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 May 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.
Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3D Super Mario Game Condition | Experimental | Behavioral: 3D navigation video game intervention3D navigation video game intervention |
| 2D Super Mario Game Condition | Active comparator | Behavioral: video game intervention without 3D navigationVideo game intervention without 3D navigation |
| Kindle Device | Active comparator | Behavioral: No 3D navigationNo 3D navigation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- clinically stabilized
- at least one schizophrenic episode in their lives
- International Classification of Diseases 10 (ICD-10) F20.x (and F25)
Key exclusion criteria (7 listed)
- clinically relevant anemia
- MRI contraindication
- earlier electroconvulsive shock treatment
- significant somatic or neurological disease
- significant alcohol or substance abuse in the year before
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 |
|---|---|---|
| 3D navigation video game interventionParticipants intensively train with a video game (Super Mario DS) | Behavioural | 3D Super Mario Game Condition |
| video game intervention without 3D navigationParticipants train with a video game (Super Mario Bros) | Behavioural | 2D Super Mario Game Condition |
| No 3D navigationParticipants read on a kindle device (control group) | Behavioural | Kindle Device |
Primary outcome
T1 - MRI
Time frame: 2 months (= training time and 2 months after training end)
The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training
Cognition - Spatial Orientation
Time frame: 2 months (= training time and 2 months after training end)
The investigators look for changes in cognition specifically regarding spatial orientation (MATRICS, computer tests measuring spatial orientation with and without external cue) due to training.
Positive & Negative Symptoms in patients
Time frame: 2 months (= training time and 2 months after training end)
The investigators look for changes in positive and negative symptoms (PANSS) due to training.
4 secondary outcomes
Resting State fMRI
Time frame: 2 months (= training time and 2 months after training end)
Spectroscopy - glutamate
Time frame: 2 month (= training time and 2 month after training end)
Diffusion Tensor Imaging (DTI)
Time frame: 2 month (= training time and 2 month after training end)
Biomarkers (BDNF & interleukin 1 & 6)
Time frame: 2 month (= training time and 2 month after training end)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Related InfoLink 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.
Maxi Becker, MSc contact
Simone Kühn, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D navigation video game intervention, video game intervention without 3D navigation and No 3D navigation in people with Schizophrenia and Healthy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 6 Jun 2018. 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 Germany. 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 Maxi Becker, MSc (max.becker@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1 - MRI (time frame: 2 months (= training time and 2 months after training end)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.