Neurophysiological Targets for Cognitive Training in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00923078
First received: June 17, 2009
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine whether computer-based training of auditory and visual processing results in corresponding improvement in brain function in individuals with schizophrenia.


Condition Intervention
Schizophrenia
Behavioral: Brain Fitness
Behavioral: Cortex with Insight

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurophysiological Targets for Cognitive Training in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • electroencephalographic recording; event-related potentials [ Time Frame: baseline; F1: 1-month follow-up (treatment crossover); F2: 2-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological test performance [ Time Frame: baseline; F1:1-month follow-up (treatment crossover); F2: 2-month follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
N = 20 participants with schizophrenia administered 4 weeks of auditory training followed by 4 weeks of visual training
Behavioral: Brain Fitness
The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Our laboratory procedures include review of progress with the participant at the end of each session, intended to encourage motivation. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory.
Other Name: Posit Science
Behavioral: Cortex with Insight
The program entails five computer-based exercises designed with the same features of Brain Fitness, which train: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view.
Other Name: Posit Science
Experimental: Arm 2
N = 20 participants with schizophrenia administered 4 weeks of visual training followed by 4 weeks of auditory training
Behavioral: Brain Fitness
The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Our laboratory procedures include review of progress with the participant at the end of each session, intended to encourage motivation. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory.
Other Name: Posit Science
Behavioral: Cortex with Insight
The program entails five computer-based exercises designed with the same features of Brain Fitness, which train: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view.
Other Name: Posit Science
No Intervention: Arm 3
N = 20 healthy community volunteers will attend a single EEG/ERP recording session to provide normative data on dependent measures investigated in the schizophrenia sample.

Detailed Description:

Schizophrenia is recognized as one of the leading causes of medical disability worldwide, ranked 9th overall by the World Health Organization, and affects more than 2 million Americans per year. There is considerable evidence to suggest that disability status in schizophrenia relates more directly to cognitive Impairment, involving attention, reasoning, and memory, than to characteristic symptoms of psychosis. Accordingly, the evaluation and advancement of interventions designed to restore cognitive function, generally termed cognitive remediation, is of critical importance to our rehabilitation mission. Recent randomized controlled trials of cognitive remediation in schizophrenia have found moderate gains in cognitive function and improved outcomes in important areas of community living. However, despite these encouraging findings, inferences that (1) brain neuroplasticity is intact in schizophrenia, (2) that training effects adaptive change at the neural level, and (3) that change in cognitive test performance occurs through restoration of underlying neural substrates, have yet to be empirically evaluated. This project will begin to address these issues by examining the effects of computer-based cognitive training on event-related potential (ERP) measures of sensory information processing. Two ERP paradigms, mismatch negativity (MMN) and P300 generation, will be administered in auditory and visual modalities. MMN and P300 have been studied extensively in human neuroscience as probes of sensory echoic memory and attention engagement to contextually relevant information. Furthermore, reductions in MMN and P300 generation are reliably observed in schizophrenia, follow the course of a progressive neuropathological process, and correlate with severity of cognitive impairment. The specific aims of this study are to determine: (1) whether training selectively influences bottom-up (MMN) or top-down (P300) information processing, (2) whether training effects are modality specific (auditory vs. visual), (3) whether baseline MMN and P300 predict, or rate-limit, training progress, and (4) whether pre-post change in cognitive test performance is mediated by neural-level change in MMN and P300 generation. Answers to these questions will provide information needed to structure cognitive training for maximum benefit in schizophrenia.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 & 70
  • minimum of 30 days since discharge from last hospitalization
  • minimum of 30 days since last change in psychiatric medications
  • receiving mental health services
  • no housing changes in the past 30 days

Exclusion Criteria:

  • current diagnosis of alcohol or substance abuse
  • history of brain trauma or neurological disease
  • chart diagnosis of mental retardation or premorbid intelligence < 70 based on Wechsler Test of Adult Reading (WTAR) full-scale estimated IQ
  • auditory or visual impairment that would interfere with study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923078

Contacts
Contact: Jason K Johannesen, PhD (203) 932-5711 ext 2224 Jason.Johannesen@va.gov

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Jason K Johannesen, PhD    203-932-5711 ext 2224    Jason.Johannesen@va.gov   
Principal Investigator: Jason K Johannesen, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jason K Johannesen, PhD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00923078     History of Changes
Other Study ID Numbers: D7008-W
Study First Received: June 17, 2009
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
schizophrenia
cognitive remediation
rehabilitation
evoked potentials
neuropsychology

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014