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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01425671
Enrollment
800
Registered
2011-08-30
Start date
2010-11-30
Completion date
2024-01-31
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

Schizophrenia, Family, Psychosis

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
14 Years to 62 Years
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Symptom and Cognition rating2 hrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026