Augmentation of Neuronal Network Plasticity in Schizophrenia

Healthy Clinical Trial

— SCZ  

Official title:

Augmentation of Neuronal Network Plasticity in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03522220
• Other study ID #: SFB936 C7
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Maxi Becker, MSc
• Email: max.becker[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Schizophrenia

Intervention

Behavioral:
• 3D navigation video game intervention
Participants intensively train with a video game (Super Mario DS)
• video game intervention without 3D navigation
Participants train with a video game (Super Mario Bros)
• No 3D navigation
Participants read on a kindle device (control group)

Locations

Country	Name	City	State
Germany	University Clinic Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1 - MRI	The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training	2 months (= training time and 2 months after training end)
Primary	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.	2 months (= training time and 2 months after training end)
Primary	Positive & Negative Symptoms in patients	The investigators look for changes in positive and negative symptoms (PANSS) due to training.	2 months (= training time and 2 months after training end)
Secondary	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	2 months (= training time and 2 months after training end)
Secondary	Spectroscopy - glutamate	The investigators look for glutamate concentration changes in the hippocampus due to the training	2 month (= training time and 2 month after training end)
Secondary	Diffusion Tensor Imaging (DTI)	The investigators look for structural connectivity changes in DTI images due to the training	2 month (= training time and 2 month after training end)
Secondary	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	2 month (= training time and 2 month after training end)

External Links

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