Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03216434
Status:
UNKNOWN
Last Update Posted:
2019-10-29
First Post:
2017-07-11
Brief Title:
Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder PTSD
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder PTSD
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being done to try to find a way to accurately diagnose post-traumatic stress syndrome PTSD in combat veteransDiagnostic biomarkers have made invaluable contributions to the diagnosis and treatment monitoring of many diseases and disorders Unfortunately PTSD currently lacks a reliable and compelling clinically-relevant biomarker The absence of a viable biomarker impairs efficient and confident diagnosis of PTSD with diminished effective care options often resulting
Detailed Description:
The possibility of developing PTSD exists when a person is exposed to death threatened death or actual or threatened serious injury either by direct exposure witnessing the trauma or learning that a close friend was exposed to this type of trauma Rates of PTSD in military personnel returning from armed conflicts may be greater than 30 The diagnosis of PTSD is based on a psychiatrists or psychologists assessment of the symptoms reported by the veteran and others such as family or friendsThe veteran with PTSD may struggle with thoughts and feelings that dont make sense or he or she believes are just not warrior-like The veteran eventually sees a mental health professional but may downplay the symptoms and fail to be correctly diagnosed This places these men and women at risk for suicide Dopamine is a substance found in our brains that has a role in regulating fear and stress as well as other emotional responses There have been studies that have shown a protein in blood called dopamine transporter DAT moves dopamine from one place to another in our brain Studies have shown that the level of DAT present has a role in PTSD In this research the researchers will evaluate the usefulness of a type of radioactive drug DaTscan which attaches to DAT and then allows the researchers to take pictures of the brain using a camera called a gamma camera This will produce images called single photon emission computed tomography SPECT The researchers are looking for a difference in these pictures in those with PTSD and veterans without PTSD and hope this can be used to help diagnose PTSD in the futureThe brain MRI is done to make sure there is not anything abnormal in the structure of the brain that could interfere with the DaTScan pictures and to accurately locate specific regions of the brain where the DaTScan pictures are especially important The MRI will also be used to look at natural nerve connections in the brain using functional MRI or fMRI The researchers will use fMRI to look for possible connection differences in brains of people with PTSD and without PTSD The DaTscan requires a drug called a radiotracer given through an intravenous IV catheter This drug is radioactive and a small amount of it will be absorbed by the thyroid gland so Lugols solution will be used to block uptake into the thyroid The length of time to complete the entire DaTscan process is approximately 5 ½ hours This includes time to receive the drug then a 3 hour break followed by about 45 minutes to take the pictures The tracer will collect in part of the brain and give off radiation gamma rays A gamma camera will produce pictures of the brainThe MRI process will take approximately 1 hour including a questionnaire about metal or implants in the subjects body Brain scanning will last for about 30 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None