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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of Maryland
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
MPRC, University of Maryland Identifier:
First received: August 28, 2011
Last updated: March 3, 2015
Last verified: March 2015
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.

Schizoaffective Disorder
Schizophreniform Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

Resource links provided by NLM:

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom and Cognition rating [ Time Frame: 2 hrs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood sample

Estimated Enrollment: 800
Study Start Date: January 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Schizophrenic patients, family members
Schizophrenia Spectrum Disorder Patients
Normal controls

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.

Ages Eligible for Study:   14 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Schizophrenic patients, family members, controls

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.
  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 identifier: NCT01425671

United States, Maryland
Maryland Psychiatric Research Center Recruiting
Baltimore, Maryland, United States, 21228
Contact: Kavita Thangavelu, MSW    410-402-6124   
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Principal Investigator: L.Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
  More Information

No publications provided

Responsible Party: MPRC, L. Elliot Hong, University of Maryland Identifier: NCT01425671     History of Changes
Other Study ID Numbers: HP-00043082  R01MH085646 
Study First Received: August 28, 2011
Last Updated: March 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features processed this record on February 11, 2016