Brain Tissue Collection for Neuropathological Studies
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||May 29, 1990|
|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 NCT00001260 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||Brain Tissue Collection for Neuropathological Studies|
|Official Title ICMJE||Brain Procurement for the Human Brain Collection Core|
The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders.
This study will ask relatives of deceased individuals to donate the brains of their deceased relatives to allow further study of neurological and psychiatric disorders. We do not accept prospective donations.
The knowledge of how affected tissue deviates from normal control tissue is an integral part of fully understanding a neurological or psychiatric disorder. The purpose of this protocol is to establish a coordinating program with the Office of the Chief Medical Examiner in Washington, DC, the Virginia Office of the Chief Medical Examiner, Central District, and Virginia the Office of the Chief Medical Examiner, Northern District for the donation of brain tissue.
Dissected brain tissue from selected brain regions, including but not limited to the dorsolateral prefrontal cortex and hippocampal formation, will be assembled from large cohorts of normal controls and schizophrenic subjects. The expression of mRNA and protein for selected molecules, chosen on the basis of their genetic association with schizophrenia, will be measured with a variety of assays including but not limited to qPCR and Western blots.
Outcome measures are the statistical comparison within normal controls of mRNA and/or protein levels in groups segmented by genotype. Similar comparisons will be made between schizophrenic cohorts and normal controls, in a diagnosis by genotype analysis with an ANOVA, or when appropriate an ANCOVA (controlling for variables such as age, race, gender, and postmortem interval).
|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 Groups/Cohorts||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||2500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, especially schizophrenia, but also anxiety disorders, suicide, bipolar disorder, depression, Tourette's Syndrome, drug addictions (PCP, cocaine, alcohol, heroin or the like) and any form of dementia. In addition, brains from normal individuals without a history of neuropsychiatric disease will be needed for controls.
No living subjects are enrolled in this protocol. Tissue is obtained after death, with the permission of next of kin, or from existing institutions with appropriate samples via an MTA or other applicable agreement.
Brain tissue is excluded from collection if there is a previously known history of strokes, lesions, or other major neuropathological abnormalities prior to the consenting process.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001260|
|Other Study ID Numbers ICMJE||900142, 90-M-0142|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Mental Health (NIMH)|
|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||December 21, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP