Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training (fMRI)
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|ClinicalTrials.gov Identifier: NCT00431223|
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : April 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive remediation therapy||Not Applicable|
Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.
After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.
Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.
Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.
All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia?|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Active Comparator: Active Group
7 patients were assigned to Cognitive Remediation Therapy..
Behavioral: Cognitive remediation therapy
36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.
Other Name: CRT Group
No Intervention: Control Group
4 patients were assigned to Control group or no cognitive remediation therapy.
- Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC) [ Time Frame: 12 weeks ]
- Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431223
|United States, New York|
|Manhattan Psychiatric Center|
|New York, New York, United States, 10035|
|Principal Investigator:||Saurabh Kaushik, MD||Manhattan Psychaitric Center|
|Study Chair:||Jean-Pierre Lindenmayer, MD||Manhattan Psychiatric Center|
|Study Chair:||Susan McGurk, PhD||Dartmouth College, Hanover|
|Study Chair:||Craig A. Branch, PhD||Center for Advanced Brain Imaging, NKI|