Augmentation of Neuronal Network Plasticity in Schizophrenia

NCT ID: NCT03522220

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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3D Super Mario Game Condition

3D navigation video game intervention

Group Type EXPERIMENTAL

3D navigation video game intervention

Intervention Type BEHAVIORAL

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

2D Super Mario Game Condition

Video game intervention without 3D navigation

Group Type ACTIVE_COMPARATOR

video game intervention without 3D navigation

Intervention Type BEHAVIORAL

Participants train with a video game (Super Mario Bros)

Kindle Device

No 3D navigation

Group Type ACTIVE_COMPARATOR

No 3D navigation

Intervention Type BEHAVIORAL

Participants read on a kindle device (control group)

Interventions

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3D navigation video game intervention

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

Intervention Type BEHAVIORAL

video game intervention without 3D navigation

Participants train with a video game (Super Mario Bros)

Intervention Type BEHAVIORAL

No 3D navigation

Participants read on a kindle device (control group)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Clinic Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Maxi Becker, MSc

Role: CONTACT

Simone Kühn, Prof

Role: CONTACT

Facility Contacts

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Maxi Becker, MSc.

Role: primary

Simone Kuehn, Prof.

Role: backup

Related Links

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Other Identifiers

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SFB936 C7

Identifier Type: -

Identifier Source: org_study_id

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