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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01781000
Other study ID # RO805/142
Secondary ID
Status Completed
Phase N/A
First received January 22, 2013
Last updated November 3, 2014
Start date December 2011
Est. completion date April 2014

Study information

Verified date November 2014
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brain Fitness & Brain Training- Posit Science
Computer aided cognitive program designed for intensive training of auditory perception, memory and attention
Facial Affect Training- FAT
Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention
Treatment as usual
standard treatment protocol of schizophrenia ward

Locations

Country Name City State
Germany University of Konstanz Konstanz Baden Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline, post-intervention (after 4 weeks), 3-months follow-up No
Secondary change from baseline in global functioning (GAF score) at 4 weeks and 3 months baseline, post-intervention, 3-months follow-up No
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