SchizophreniaNCT01781000
Cerebral Reorganization in Schizophrenia
A study testing Brain Fitness & Brain Training- Posit Science, Facial Affect Training- FAT and Treatment as usual in people with Schizophrenia, run by University of Konstanz at 1 site in Germany.
Trial summary
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brain Fitness & Brain Training- Posit Science, Facial Affect Training- FAT and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Intact auditory perception
- Intact visual perception
Who cannot join
- Mental retardation
- Age over 60
- Insufficient German language knowledge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Brain Fitness & Brain Training- Posit Science, Facial Affect Training- FAT, Treatment as usual
- Keywords
- Cognitive Training, Neuroplasticity, MEG, MATRICS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness & Brain Training- Posit ScienceBehavioural
Computer aided cognitive program designed for intensive training of auditory perception, memory and attention
Facial Affect Training- FATBehavioural
Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention
Treatment as usualBehavioural
standard treatment protocol of schizophrenia ward
| Study group | Role | What they receive |
|---|---|---|
| Auditiory verbal discrimination training | Experimental | Brain Fitness \& Brain Training- Posit Science Receives: Behavioral: Brain Fitness & Brain Training- Posit Science |
| Facial affect discrimination training | Experimental | Behavioral: Facial Affect Training- FAT Receives: Behavioral: Facial Affect Training- FAT |
| Treatment as usual | Active comparator | standard treatment/rehabilitation protocol of schizophrenia ward Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, post-intervention (after 4 weeks), 3-months follow-up
Secondary outcomes (1)
change from baseline in global functioning (GAF score) at 4 weeks and 3 months
Measured: baseline, post-intervention, 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Brigitte Rockstroh, University of Konstanz
- Investigators
- Brigitte Rockstroh, Prof. Dr., Study chair, University Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781000
- Sponsor's protocol ID
- RO805/142
- Status last verified
- Nov 2014
- First submitted
- 22 Jan 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25379427
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training-induced Cerebral Reorganization in Schizophrenia
- ClinicalTrials.gov ID
- NCT01781000
- Acronym / sponsor ID
- RO805/142
- Conditions
- Schizophrenia
- Keywords
- Cognitive Training, Neuroplasticity, MEG, MATRICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auditiory verbal discrimination training | Experimental | Behavioral: Brain Fitness & Brain Training- Posit ScienceBrain Fitness \& Brain Training- Posit Science |
| Facial affect discrimination training | Experimental | Behavioral: Facial Affect Training- FATBehavioral: Facial Affect Training- FAT |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualstandard treatment/rehabilitation protocol of schizophrenia ward |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Intact auditory perception
- Intact visual perception
Key exclusion criteria (3 listed)
- Mental retardation
- Age over 60
- Insufficient German language knowledge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Fitness & Brain Training- Posit ScienceComputer aided cognitive program designed for intensive training of auditory perception, memory and attention | Behavioural | Auditiory verbal discrimination training |
| Facial Affect Training- FATComputer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention | Behavioural | Facial affect discrimination training |
| Treatment as usualstandard treatment protocol of schizophrenia ward | Behavioural | Treatment as usual |
Primary outcome
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
1 secondary outcome
change from baseline in global functioning (GAF score) at 4 weeks and 3 months
Time frame: baseline, post-intervention, 3-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Background: PubMed 25379427Popova 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.
- Brain Training SoftwareLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Rockstroh, Prof. Dr. study chair
University Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Fitness & Brain Training- Posit Science, Facial Affect Training- FAT and Treatment as usual in people with Schizophrenia, run by University of Konstanz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014; AzTrials last refreshed its copy on 1 Nov 2026.