Augmentation of Neuronal Network Plasticity in Schizophrenia (SCZ)
Primary Purpose
Schizophrenia, Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
3D navigation video game intervention
video game intervention without 3D navigation
No 3D navigation
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia
Eligibility 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)
Sites / Locations
- University Clinic Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
3D Super Mario Game Condition
2D Super Mario Game Condition
Kindle Device
Arm Description
3D navigation video game intervention
Video game intervention without 3D navigation
No 3D navigation
Outcomes
Primary Outcome Measures
T1 - MRI
The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training
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.
Positive & Negative Symptoms in patients
The investigators look for changes in positive and negative symptoms (PANSS) due to training.
Secondary Outcome Measures
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
Spectroscopy - glutamate
The investigators look for glutamate concentration changes in the hippocampus due to the training
Diffusion Tensor Imaging (DTI)
The investigators look for structural connectivity changes in DTI images due to the training
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
Full Information
NCT ID
NCT03522220
First Posted
April 30, 2018
Last Updated
June 4, 2018
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT03522220
Brief Title
Augmentation of Neuronal Network Plasticity in Schizophrenia
Acronym
SCZ
Official Title
Augmentation of Neuronal Network Plasticity in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D Super Mario Game Condition
Arm Type
Experimental
Arm Description
3D navigation video game intervention
Arm Title
2D Super Mario Game Condition
Arm Type
Active Comparator
Arm Description
Video game intervention without 3D navigation
Arm Title
Kindle Device
Arm Type
Active Comparator
Arm Description
No 3D navigation
Intervention Type
Behavioral
Intervention Name(s)
3D navigation video game intervention
Intervention Description
Participants intensively train with a video game (Super Mario DS)
Intervention Type
Behavioral
Intervention Name(s)
video game intervention without 3D navigation
Intervention Description
Participants train with a video game (Super Mario Bros)
Intervention Type
Behavioral
Intervention Name(s)
No 3D navigation
Intervention Description
Participants read on a kindle device (control group)
Primary Outcome Measure Information:
Title
T1 - MRI
Description
The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training
Time Frame
2 months (= training time and 2 months after training end)
Title
Cognition - Spatial Orientation
Description
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.
Time Frame
2 months (= training time and 2 months after training end)
Title
Positive & Negative Symptoms in patients
Description
The investigators look for changes in positive and negative symptoms (PANSS) due to training.
Time Frame
2 months (= training time and 2 months after training end)
Secondary Outcome Measure Information:
Title
Resting State fMRI
Description
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
Time Frame
2 months (= training time and 2 months after training end)
Title
Spectroscopy - glutamate
Description
The investigators look for glutamate concentration changes in the hippocampus due to the training
Time Frame
2 month (= training time and 2 month after training end)
Title
Diffusion Tensor Imaging (DTI)
Description
The investigators look for structural connectivity changes in DTI images due to the training
Time Frame
2 month (= training time and 2 month after training end)
Title
Biomarkers (BDNF & interleukin 1 & 6)
Description
The investigators look for plasticity induced changes in biomarkers (interleukin1 and 6 and BDNF [brain-derived neurotrophic factor]) due to training
Time Frame
2 month (= training time and 2 month after training end)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxi Becker, MSc
Email
max.becker@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Kühn, Prof
Email
s.kuehn@uke.de
Facility Information:
Facility Name
University Clinic Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxi Becker, MSc.
Email
max.becker@uke.de
First Name & Middle Initial & Last Name & Degree
Simone Kuehn, Prof.
Email
s.kuehn@uke.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.sfb936.net/thematic-area-c
Description
Related Info
Learn more about this trial
Augmentation of Neuronal Network Plasticity in Schizophrenia
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