Neurophysiological Targets for Cognitive Training in Schizophrenia

NCT00923078 | Completed Results

• 1 other identifier: D7008-W
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenia; cognitive remediation; rehabilitation; electrophysiology; neuropsychology

Outcome Measures

Primary Outcomes (3)

• Visual Target Detection (P300 Event-related Potential Amplitude) Change

  Visual P300 was measured in a 3-stimulus target detection task with target stimuli (10%; large circle) presented in pseudo random order amidst a series of novel (10%; fractal), and standard (80%; small circle) images on a 24" LCD monitor at 100cm viewing distance. Subjects are instructed to press a reaction time button with the preferred hand to Targets only, giving equal importance to speed and accuracy. Primary analysis are based on Target "P300b" identified as the most positive amplitude deflection within the window of 250-550ms post stimulus at posterior midline electrode Pz. The P300b component is thought to reflect cognitive processes involved in memory updating and decision making. P300 reported as difference scores from baseline with negative values indicating increased P300.

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

• Auditory Mismatch Negativity (MMN) Amplitude Change

  Auditory MMN is a fronto-central, mid-latency, potential generated by the auditory cortex in response to deviation in a repetitive stimulus sequence. MMN was assessed using a 3-deviant paradigm in which a series of standard tones (633 Hz, 50ms duration,90%) is interrupted by deviants (10%) that differ either by (1) pitch (1000Hz, 50ms), (2) duration (633 Hz, 100ms), or (3) both (1000Hz, 100ms). MMN was tested concurrently with Visual P300 using a combined task in which subjects were instructed to ignore the auditory stimuli and focus on the visual stimuli. MMN is scored by subtracting each deviant ERP waveform from the standard waveform and measuring the most negative deflection in a window of 50 to 265ms post-stimulus from the resulting difference wave. Primary analysis is based on the combined deviant condition scored at the frontal midline (Fz) electrode site. MMN reported as difference scores from baseline with positive values indicating increased MMN.

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

• MCCB Cognitive Composite Score Change

  The Cognitive Composite score is derived from the MATRICS Consensus Cognitive Battery (MCCB). The MCCB consists of 10 tests and provides standard scores for each according to seven cognitive domains: (1) speed of processing, (2) attention/vigilance, (3) working memory (verbal and visual), (4) verbal learning, (5) visual learning, (6) reasoning and problem solving, and (7) social cognition. The primary dependent measures derived from the MCCB for purpose of this study is the cognitive composite score, computed as the average of standard (t-scores) scores from each domain excluding social cognition. MCCB Composite reported as difference scores from baseline with negative values indicating higher test performance.

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

Secondary Outcomes (4)

• Visual Learning (BVMT-R) Change

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

• Verbal Learning (HVLT-R) Change

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

• Visual Working Memory (Spatial Span) Change

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

• Auditory Working Memory (LNS) Change

  Baseline; Post 4 weeks (treatment crossover); Post 8 weeks

Study Arms (2)

Auditory-Visual Train Order

EXPERIMENTAL

4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) followed by 4 weeks (20 sessions) of visual cognitive training (Insight)

Behavioral: Auditory Cognitive Training; Behavioral: Visual Cognitive Training

Visual-Auditory Train Order

EXPERIMENTAL

4 weeks (20 sessions) of visual cognitive training (Insight) followed by 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)

Behavioral: Auditory Cognitive Training; Behavioral: Visual Cognitive Training

Interventions

Auditory Cognitive Training BEHAVIORAL

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. 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. Training was administered in a supervised clinical laboratory setting at a frequency of five 60-minute sessions per week over 4 weeks.

Also known as: Brain Fitness by Posit Science

Auditory-Visual Train Order; Visual-Auditory Train Order

Visual Cognitive Training BEHAVIORAL

The program entails five 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, following our laboratory procedures, calibration testing is repeated every 5th session. Exercises adapt in difficulty to individual performance, giving constant feedback about progress. Each of the five exercises focuses on a distinct process: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view. Training was administered in a supervised clinical laboratory setting at a frequency of five 40-minute sessions per week over 4 weeks.

Also known as: Cortex with Insight by Posit Science

Auditory-Visual Train Order; Visual-Auditory Train Order

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder
• 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

You may not qualify if:

• 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
• a sample of 20 healthy community volunteers was also recruited according to these criteria and tested, without intervention, as a normative reference sample for MMN and P300 measures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Jason K. Johannesen
• Organization: VA Connecticut Healthcare System

jason.johannesen@va.gov

2039325711

Study Officials

• Jason K Johannesen, PhD

  VA Connecticut Health Care System (West Haven)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: November 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 22, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)