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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
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 30, 2018
Last Updated
June 4, 2018
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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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

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Augmentation of Neuronal Network Plasticity in Schizophrenia

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