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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01425671

Collaborator

National Institute of Mental Health (NIMH) (NIH)

800

Enrollment

Location

138

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 30, 2010

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Schizophrenic patients, family members Schizophrenia Spectrum Disorder Patients
Controls Normal controls

Outcome Measures

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. [10-12 hours]

Secondary Outcome Measures

Symptom and Cognition rating [2 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Maryland Psychiatric Research Center	Baltimore	Maryland	United States	21228

Sponsors and Collaborators

University of Maryland, Baltimore
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: L.Elliot Hong, M.D., Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine