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Cerebral Reorganization in Schizophrenia

This study is currently recruiting participants.
Verified January 2013 by University of Konstanz
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Brigitte Rockstroh, University of Konstanz
ClinicalTrials.gov Identifier:
NCT01781000
First received: January 22, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia


Condition Intervention
Schizophrenia
 Behavioral: Brain Fitness & Brain Training- Posit Science
Behavioral: Facial Affect Training- FAT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Training-induced Cerebral Reorganization in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by University of Konstanz:

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 [ Time Frame: baseline, post-intervention (after 4 weeks), 3-months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in global functioning (GAF score) at 4 weeks and 3 months [ Time Frame: baseline, post-intervention, 3-months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auditiory verbal discrimination training
Brain Fitness & Brain Training- Posit Science
 Behavioral: 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
 Behavioral: Facial Affect Training- FAT
Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781000

Contacts
Contact: Brigitte Rockstroh, Prof. Dr. brigitte.rockstroh@uni-konstanz.de
Contact: Tzvetan Popov, Dr. tzvetan.popov@uni-konstanz.de

Locations
Germany
University of Konstanz Recruiting
Konstanz, Baden Württemberg, Germany, 78464
Contact: Tzvetan Popov, Dr.     +497531883086     tzvetan.popov@uni-konstanz.de    
Sub-Investigator: Tzvetan Popov, Dr.            
Sponsors and Collaborators
University of Konstanz
Investigators
Study Chair: Brigitte Rockstroh, Prof. Dr. University Konstanz
  More Information

Additional Information:
Brain Training Software  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Dr. Brigitte Rockstroh, Prof. Dr., University of Konstanz
ClinicalTrials.gov Identifier: NCT01781000     History of Changes
Other Study ID Numbers: RO805/142
Study First Received: January 22, 2013
Last Updated: January 29, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Konstanz:
Cognitive Training
Neuroplasticity
MEG
MATRICS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013