Brain Tissue Collection for Neuropathological Studies
|ClinicalTrials.gov Identifier: NCT00001260|
Recruitment Status : Terminated
First Posted : November 4, 1999
Last Update Posted : February 23, 2018
|First Submitted Date||November 3, 1999|
|First Posted Date||November 4, 1999|
|Last Update Posted Date||February 23, 2018|
|Start Date||May 29, 1990|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00001260 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Brain Tissue Collection for Neuropathological Studies|
|Official Title||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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||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.
|Estimated Completion Date||June 16, 2017|
|Primary Completion Date||Not Provided|
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|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||900142
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )|
|Study Sponsor||National Institute of Mental Health (NIMH)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 16, 2017|