NCT03522220

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

April 30, 2018

Last Update Submit

June 4, 2018

Conditions

SchizophreniaHealthy

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Resting State fMRI

    2 months (= training time and 2 months after training end)

  • Spectroscopy - glutamate

    2 month (= training time and 2 month after training end)

  • Diffusion Tensor Imaging (DTI)

    2 month (= training time and 2 month after training end)

  • Biomarkers (BDNF & interleukin 1 & 6)

    2 month (= training time and 2 month after training end)

Study Arms (3)

3D Super Mario Game Condition

EXPERIMENTAL

3D navigation video game intervention

Behavioral: 3D navigation video game intervention

2D Super Mario Game Condition

ACTIVE COMPARATOR

Video game intervention without 3D navigation

Behavioral: video game intervention without 3D navigation

Kindle Device

ACTIVE COMPARATOR

No 3D navigation

Behavioral: No 3D navigation

Interventions

3D navigation video game interventionBEHAVIORAL

Participants intensively train with a video game (Super Mario DS)

3D Super Mario Game Condition
video game intervention without 3D navigationBEHAVIORAL

Participants train with a video game (Super Mario Bros)

2D Super Mario Game Condition
No 3D navigationBEHAVIORAL

Participants read on a kindle device (control group)

Kindle Device

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • clinically stabilized
  • at least one schizophrenic episode in their lives
  • International Classification of Diseases 10 (ICD-10) F20.x (and F25)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Maxi Becker, MSc

CONTACT

max.becker@uke.de

Simone Kühn, Prof

CONTACT

s.kuehn@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

September 1, 2016

Primary Completion

July 31, 2019

Study Completion

December 31, 2019

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

DE(1)