Electrophysiology and Blood Flow in Patients With Schizophrenia and Their Siblings
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||September 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001921 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Electrophysiology and Blood Flow in Patients With Schizophrenia and Their Siblings|
|Official Title ICMJE||Integrating EEG/MEG and fMRI: Activity Correlation Between Frontal and Temporal Lobe Structures in Schizophrenic Patients, Their Siblings and Unrelated Normal Volunteers|
This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties.
Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied.
Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity.
It is the aim of this study to investigate the functional activation and coupling between brain regions in normals, patients with schizophrenia and unaffected family members. We will perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of oscillatory brain activity as this is considered to be crucial for information processing related to neuronal integration. The measurements will be closely adapted to equivalent fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both methods will help to improve activity source localization (MEG/EEG) and correlation of this activity between different parts of the brain. In addition, local activity patterns (fMRI) can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will address whether cognitive activation goes along with an increase or decrease of correlation between regional brain areas. In this context, we will investigate whether this correlated activation pattern is different in schizophrenics and unaffected siblings when compared with normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings of schizophrenic patients are investigated in order to achieve a better understanding of the genetic determination of schizophrenia-related pathophysiology.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
1) Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient evaluation of neuropsychiatric inpatients", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator).
Controls and patients:
|Ages||18 Years to 55 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001921|
|Other Study ID Numbers ICMJE||990172, 99-M-0172|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP