fMRI: Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training

Sponsor

Manhattan Psychiatric Center (Other)

Overall Status

Completed

CT.gov ID

NCT00431223

Collaborator

Nathan Kline Institute for Psychiatric Research (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Cognitive remediation therapy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia?

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: CRT Group
No Intervention: Control Group 4 patients were assigned to Control group or no cognitive remediation therapy.

Arm

Intervention/Treatment

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 Names:

CRT Group

No Intervention: Control Group

4 patients were assigned to Control group or no cognitive remediation therapy.

Outcome Measures

Primary Outcome Measures

Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC) [12 weeks]

Secondary Outcome Measures

Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Inpatient status
Age 18 - 55
Male gender (females are enrolled but will not be scanned)
DSM-IV diagnosis of schizophrenia (all subtypes) and schizoaffective disorder
illness duration > 5 years
MMSE score > 24 (inclusive) at screening
Stable dose of oral atypical antipsychotic for at least 4 weeks prior to study entry
Total PANSS score > 60 at screening
Capacity and willingness to give written informed consent
Patients deemed not ready to be discharged within the next 12 weeks

Exclusion Criteria:

Inability to read or speak English
Documented disease of the central nervous system
History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or hematological conditions; HIV positive
Any medical condition rendering the subject unable to receive an fMRI scan