SchizophreniaNCT00695708
Training-induced Cerebral Reorganization in Schizophrenia
A study testing Brain Fitness Program and Cogpack 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 effects of computer-aided cognitive-auditory training on cerebral reorganization in schizophrenia. Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brain Fitness Program and Cogpack
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jan 2010
- 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 Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Intact hearing abilities
Who cannot join
- Mental retardation
- Age over 60
- Insufficient German language knowledge
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reveal the effects of computer-aided cognitive-auditory 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 involves a variability of cognitive abilities.
Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.
- Conditions
- Schizophrenia
- Being tested
- Brain Fitness Program, Cogpack
- Keywords
- schizophrenia, neuroplasticity, sensory gating, cognitive impairment, MEG, Disorders with Psychotic Features
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness ProgramBehavioural
Computer-aided cognitive program designed for intensive training of auditory perception, memory and attention
CogpackBehavioural
Computer-aided cognitive program for cognitive abilities
| Study group | Role | What they receive |
|---|---|---|
| BFT | Experimental | 20 schizophrenic patients Receives: Behavioral: Brain Fitness Program |
| CP | Active comparator | 19 schizophrenic patients Receives: Behavioral: Cogpack |
| HCG | No intervention | 20 healthy age and sex matched subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event related potential MEG, test scores in word fluency and verbal learning tasks
Measured: pre and post intervention
Secondary outcomes (1)
Symptom severity, GAF score
Measured: pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJan 2010
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Brigitte Rockstroh, Prof. Dr., Study chair, University of Konstanz, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695708
- Sponsor's protocol ID
- RO 805/14
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21092939
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training-induced Cerebral Reorganization in Schizophrenia
- ClinicalTrials.gov ID
- NCT00695708
- Acronym / sponsor ID
- RO 805/14
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, neuroplasticity, sensory gating, cognitive impairment, MEG, Disorders with Psychotic Features
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jun 2008 (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 effects of computer-aided cognitive-auditory 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 involves a variability of cognitive abilities.
Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BFT | Experimental | Behavioral: Brain Fitness Program20 schizophrenic patients |
| CP | Active comparator | Behavioral: Cogpack19 schizophrenic patients |
| HCG | No intervention | –20 healthy age and sex matched subjects |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Intact hearing abilities
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 ProgramComputer-aided cognitive program designed for intensive training of auditory perception, memory and attention | Behavioural | BFT |
| CogpackComputer-aided cognitive program for cognitive abilities | Behavioural | CP |
Primary outcome
Event related potential MEG, test scores in word fluency and verbal learning tasks
Time frame: pre and post intervention
1 secondary outcome
Symptom severity, GAF score
Time frame: pre and post intervention
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 13 Apr 2010.
- Derived from this study: PubMed 21092939Popov 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.
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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 of Konstanz, Department of Psychology
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 Program and Cogpack 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 2 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 13 Apr 2010. 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?
Event related potential MEG, test scores in word fluency and verbal learning tasks (time frame: pre and post intervention). 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 NCT00695708, 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 13 Apr 2010.