NCT00695708

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 13, 2010

Status Verified

June 1, 2008

Enrollment Period

1.4 years

First QC Date

June 9, 2008

Last Update Submit

April 12, 2010

Conditions

Schizophrenia

Keywords

schizophrenianeuroplasticitysensory gatingcognitive impairmentMEGDisorders with Psychotic Features

Outcome Measures

Primary Outcomes (1)

  • Event related potential MEG, test scores in word fluency and verbal learning tasks

    pre and post intervention

Secondary Outcomes (1)

  • Symptom severity, GAF score

    pre and post intervention

Study Arms (3)

BFT

EXPERIMENTAL

20 schizophrenic patients

Behavioral: Brain Fitness Program

CP

ACTIVE COMPARATOR

19 schizophrenic patients

Behavioral: Cogpack

HCG

NO INTERVENTION

20 healthy age and sex matched subjects

Interventions

Brain Fitness ProgramBEHAVIORAL

Computer-aided cognitive program designed for intensive training of auditory perception, memory and attention

BFT
CogpackBEHAVIORAL

Computer-aided cognitive program for cognitive abilities

CP

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of schizophrenia and disorders with psychotic features
  • Intact hearing abilities

You may not qualify if:

  • Mental retardation
  • Age over 60
  • Insufficient German language knowledge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz

Konstanz, Baden Württenberg, 78457, Germany

Location

Related Publications (1)

  • Popov T, Jordanov T, Rockstroh B, Elbert T, Merzenich MM, Miller GA. Specific cognitive training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol Psychiatry. 2011 Mar 1;69(5):465-71. doi: 10.1016/j.biopsych.2010.09.028. Epub 2010 Nov 18.

    PMID: 21092939DERIVED

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Brigitte Rockstroh, Prof. Dr.

    University of Konstanz, Department of Psychology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

April 13, 2010

Record last verified: 2008-06

Locations

DE(1)