NCT02588014

Brief Summary

The purpose of this project is to examine potential mechanisms that may underlie early visual and auditory perception as well as visual and auditory affect perception deficits in schizophrenia and the possible connection between these processes. Given that affect perception largely involves visual and/or auditory information processing and likely relies on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine affect perception deficits within the framework of the more basic visual and auditory processes. Specifically, the investigators will examine magnetophysiological correlates of vocal and visual affect discrimination, non-affective face discrimination and voice discrimination, and simple visual and auditory stimulus discrimination, using Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

October 26, 2015

Last Update Submit

October 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brain responses to early visual and auditory stimuli as measured by the MEG

    Amplitudes and brain sources of early auditory and visual components as measured by the MEG

    Immediate

Secondary Outcomes (2)

  • Correlation between brain responses to early visual and auditory processing and brain patterns of affect perception

    Immediate

  • Correlation between brain responses to early visual and auditory processing and social functioning and quality of life questionnaire' grades

    Immediate

Study Arms (2)

Schizophrenia

Individuals with schizophrenia

Other: Magnetoencephalography

Control

Neurotypical individuals

Other: Magnetoencephalography

Interventions

Magnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced.

Also known as: MEG, 4D-NeuroImage
ControlSchizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with schizophrenia

You may qualify if:

  • Capable and willing to provide informed consent
  • Diagnosis of schizophrenia or schizoaffective
  • Right handedness
  • Corrected visual acuity
  • No color blindness
  • Normal hearing
  • IQ ≥ 70
  • Capable and willing to provide informed consent
  • Right handedness
  • Corrected visual acuity
  • No color blindness
  • Normal hearing
  • IQ ≥ 70

You may not qualify if:

  • Left handedness
  • Intellectual Disability
  • Impaired vision
  • Impaired hearing
  • Colour blindness
  • History of significant head injury or neurological illness
  • Current diagnosis of substance dependence
  • Metallic implants
  • Severe current mental instability that precludes participation in the MEG task
  • Psychiatric history
  • Intellectual Disability
  • Impaired vision
  • Impaired hearing
  • Colour blindness
  • History of significant head injury or neurological illness
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Officials

  • Yuval Bloch, MD

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

December 1, 2019

Last Updated

October 27, 2015

Record last verified: 2015-10