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

October 2, 2020 updated by: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10035
        • Manhattan Psychiatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Psychiatric Center

Collaborators

Nathan Kline Institute for Psychiatric Research

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (ESTIMATE)

February 5, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05I/C52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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