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Augmentation of Neuronal Network Plasticity in Schizophrenia (SCZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522220
Recruitment Status : Unknown
Verified June 2018 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Recruiting
First Posted : May 11, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Healthy Behavioral: 3D navigation video game intervention Behavioral: video game intervention without 3D navigation Behavioral: No 3D navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Augmentation of Neuronal Network Plasticity in Schizophrenia
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 3D Super Mario Game Condition
3D navigation video game intervention
Behavioral: 3D navigation video game intervention
Participants intensively train with a video game (Super Mario DS)

Active Comparator: 2D Super Mario Game Condition
Video game intervention without 3D navigation
Behavioral: video game intervention without 3D navigation
Participants train with a video game (Super Mario Bros)

Active Comparator: Kindle Device
No 3D navigation
Behavioral: No 3D navigation
Participants read on a kindle device (control group)




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Resting State fMRI [ Time Frame: 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

  2. Spectroscopy - glutamate [ Time Frame: 2 month (= training time and 2 month after training end) ]
    The investigators look for glutamate concentration changes in the hippocampus due to the training

  3. Diffusion Tensor Imaging (DTI) [ Time Frame: 2 month (= training time and 2 month after training end) ]
    The investigators look for structural connectivity changes in DTI images due to the training

  4. Biomarkers (BDNF & interleukin 1 & 6) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522220


Contacts
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Contact: Maxi Becker, MSc max.becker@uke.de
Contact: Simone Kühn, Prof s.kuehn@uke.de

Locations
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Germany
University Clinic Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Maxi Becker, MSc.       max.becker@uke.de   
Contact: Simone Kuehn, Prof.       s.kuehn@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Additional Information:
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03522220    
Other Study ID Numbers: SFB936 C7
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders