Augmentation of Neuronal Network Plasticity in Schizophrenia

Not Applicable

• Conditions: Healthy; Schizophrenia
• Interventions: Behavioral: No 3D navigation; Behavioral: 3D navigation video game intervention; Behavioral: video game intervention without 3D navigation

• Registration Number: NCT03522220
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• clinically stabilized
• at least one schizophrenic episode in their lives
• International Classification of Diseases 10 (ICD-10) F20.x (and F25)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Kindle Device	No 3D navigation	No 3D navigation
3D Super Mario Game Condition	3D navigation video game intervention	3D navigation video game intervention
2D Super Mario Game Condition	video game intervention without 3D navigation	Video game intervention without 3D navigation

Primary Outcome Measures

Name	Time	Method
Cognition - Spatial Orientation	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	2 months (= training time and 2 months after training end)	The investigators look for changes in positive and negative symptoms (PANSS) due to training.
T1 - MRI	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

Secondary Outcome Measures

Name	Time	Method
Diffusion Tensor Imaging (DTI)	2 month (= training time and 2 month after training end)	The investigators look for structural connectivity changes in DTI images due to the training
Spectroscopy - glutamate	2 month (= training time and 2 month after training end)	The investigators look for glutamate concentration changes in the hippocampus due to the training
Resting State fMRI	2 months (= training time and 2 months after training end)	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
Biomarkers (BDNF & interleukin 1 & 6)	2 month (= training time and 2 month after training end)	The investigators look for plasticity induced changes in biomarkers (interleukin1 and 6 and BDNF \[brain-derived neurotrophic factor\]) due to training

Trial Locations

Locations (1)

University Clinic Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany