Back to resultsCerebral Reorganization in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brain Fitness & Brain Training- Posit Science
Facial Affect Training- FAT
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Training, Neuroplasticity, MEG, MATRICS
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Intact auditory perception
- Intact visual perception
Exclusion Criteria:
- Mental retardation
- Age over 60
- Insufficient German language knowledge
Sites / Locations
- University of Konstanz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Auditiory verbal discrimination training
Facial affect discrimination training
Treatment as usual
Arm Description
Brain Fitness & Brain Training- Posit Science
Behavioral: Facial Affect Training- FAT
standard treatment/rehabilitation protocol of schizophrenia ward
Outcomes
Primary Outcome Measures
change from baseline at post-intervention (4-weeks) and 3-months in each to the primary outcome measures: neuropsychological test scores (MCCB), MEG alpha oscillations
Secondary Outcome Measures
change from baseline in global functioning (GAF score) at 4 weeks and 3 months
Full Information
NCT ID
NCT01781000
First Posted
January 22, 2013
Last Updated
November 3, 2014
Sponsor
University of Konstanz
1. Study Identification
Unique Protocol Identification Number
NCT01781000
Brief Title
Cerebral Reorganization in Schizophrenia
Official Title
Training-induced Cerebral Reorganization in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia
Detailed Description
Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. In this study we compare effects of two computer-aided training programs. One focused on auditory perception and processing as a basic ability underlying higher order information processing. The other training focus on facial affect discrimination and working memory. Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive Training, Neuroplasticity, MEG, MATRICS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auditiory verbal discrimination training
Arm Type
Experimental
Arm Description
Brain Fitness & Brain Training- Posit Science
Arm Title
Facial affect discrimination training
Arm Type
Experimental
Arm Description
Behavioral: Facial Affect Training- FAT
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
standard treatment/rehabilitation protocol of schizophrenia ward
Intervention Type
Behavioral
Intervention Name(s)
Brain Fitness & Brain Training- Posit Science
Intervention Description
Computer aided cognitive program designed for intensive training of auditory perception, memory and attention
Intervention Type
Behavioral
Intervention Name(s)
Facial Affect Training- FAT
Intervention Description
Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
standard treatment protocol of schizophrenia ward
Primary Outcome Measure Information:
Title
change from baseline at post-intervention (4-weeks) and 3-months in each to the primary outcome measures: neuropsychological test scores (MCCB), MEG alpha oscillations
Time Frame
baseline, post-intervention (after 4 weeks), 3-months follow-up
Secondary Outcome Measure Information:
Title
change from baseline in global functioning (GAF score) at 4 weeks and 3 months
Time Frame
baseline, post-intervention, 3-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of schizophrenia and disorders with psychotic features
Intact auditory perception
Intact visual perception
Exclusion Criteria:
Mental retardation
Age over 60
Insufficient German language knowledge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Rockstroh, Prof. Dr.
Organizational Affiliation
University Konstanz
Official's Role
Study Chair
Facility Information:
Facility Name
University of Konstanz
City
Konstanz
State/Province
Baden Württemberg
ZIP/Postal Code
78464
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25379427
Citation
Popova P, Popov TG, Wienbruch C, Carolus AM, Miller GA, Rockstroh BS. Changing facial affect recognition in schizophrenia: effects of training on brain dynamics. Neuroimage Clin. 2014 Sep 4;6:156-65. doi: 10.1016/j.nicl.2014.08.026. eCollection 2014.
Results Reference
background
Links:
URL
http://www.positscience.com/
Description
Brain Training Software
Learn more about this trial
Cerebral Reorganization in Schizophrenia
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