Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training (fMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431223
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : April 16, 2015
Nathan Kline Institute for Psychiatric Research
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: CRT Group

No Intervention: Control Group
4 patients were assigned to Control group or no cognitive remediation therapy.

Primary Outcome Measures :
  1. Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431223

United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
Nathan Kline Institute for Psychiatric Research
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

Additional Information:
Responsible Party: Jean-Pierre Lindenmayer, Clinical Director, Manhattan Psychiatric Center Identifier: NCT00431223     History of Changes
Other Study ID Numbers: 05I/C52
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center:
working memory
treatment refractory
cognitive skills training
dorsolateral prefrontal cortex
cognitive remediation
treatment refractory schizophrenia of > 5 years duration

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders