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Clinical Trials/NCT01425671
NCT01425671
Completed
Not Applicable

Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

University of Maryland, Baltimore1 site in 1 country800 target enrollmentNovember 30, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Maryland, Baltimore
Enrollment
800
Locations
1
Primary Endpoint
We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients.

Detailed Description

There are several studies and hypotheses to be tested. This project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. Subjects are expected to do a brain wave recording (EEG/ERP), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. Expected duration of subject participation will be approximately 8 hours (about 2 visits). Outcome measures includes biomarkers, clinical symptoms and function, and genetic information.

Registry
clinicaltrials.gov
Start Date
November 30, 2010
End Date
January 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

L. Elliot Hong

L. Elliot Hong

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Male and Female between ages 14-62 (clinical assessment and blood draw only above 62)
  • Ability to give written assent (subjects who are below the age of 18)
  • Ability to give written informed consent (age 18 or above)
  • Sufficient understanding of the study and risks (ESC score 10 or above)
  • Subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw.

Exclusion Criteria

  • Inability to sign informed consent/assent
  • Any major medical illness that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, an other significant brain neurological conditions.
  • Significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
  • Woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test).
  • Can not refrain from using alcohol and/or marijuana 24 hours or more\& cigarette smoking half and hour or more prior to experiments.

Outcomes

Primary Outcomes

We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task.

Time Frame: 10-12 hours

Secondary Outcomes

  • Symptom and Cognition rating(2 hrs)

Study Sites (1)

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