- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781000
Cerebral Reorganization in Schizophrenia
November 3, 2014 updated by: Prof. Dr. Brigitte Rockstroh, University of Konstanz
Training-induced Cerebral Reorganization in Schizophrenia
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
80
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
-
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Baden Württemberg
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Konstanz, Baden Württemberg, Germany, 78464
- University of Konstanz
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auditiory verbal discrimination training
Brain Fitness & Brain Training- Posit Science
|
Computer aided cognitive program designed for intensive training of auditory perception, memory and attention
|
Experimental: Facial affect discrimination training
Behavioral: Facial Affect Training- FAT
|
Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention
|
Active Comparator: Treatment as usual
standard treatment/rehabilitation protocol of schizophrenia ward
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standard treatment protocol of schizophrenia ward
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline, post-intervention (after 4 weeks), 3-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in global functioning (GAF score) at 4 weeks and 3 months
Time Frame: baseline, post-intervention, 3-months follow-up
|
baseline, post-intervention, 3-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Brigitte Rockstroh, Prof. Dr., University Konstanz
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
December 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RO805/142
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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