Augmentation of Neuronal Network Plasticity in Schizophrenia (SCZ)

June 4, 2018 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months (= training time and 2 months after training end)
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.
2 months (= training time and 2 months after training end)
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.
2 months (= training time and 2 months after training end)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months (= training time and 2 months after training end)
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
2 month (= training time and 2 month after training end)
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
2 month (= training time and 2 month after training end)
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
2 month (= training time and 2 month after training end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFB936 C7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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