Developing Therapies for Traumatic Brain Injury

Stopped early

Conditions studied: Traumatic Brain Injury

In brief

Background: \- A person who has a traumatic brain injury (TBI) -- also called concussion -- can have serious and long-lasting effects. Doctors who treat TBI need more information about how the brain changes over time in people with TBI and how well a person recovers from it. To make existing TBI treatments more effective and develop new ones, researchers want to look more closely at how TBI affects people both physically and psychologically. Objectives: \- To collect medical information from people with recent traumatic brain injury and compare this information to that of healthy volunteers and of persons who have had injuries to other parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after surgery). Eligibility: 3 groups of people between the ages of 18 and 70 years will be asked to take part. * Persons who have had a traumatic brain injury (or concussion ) within the past 30 days, OR * Persons who are healthy and have never had a traumatic brain injury, OR * Persons who have had an injury within the past 30 days to a part of their body other than the head (such as a broken bone, orthopedic injury, surgery) Design: * This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit within 30 days of their injury. * Screening: Participants will be screened with a medical history, physical examination, blood tests and electrocradiogram (ECG a routine heart test). * The research will involve: 1. Giving blood samples (no more than 75 ml each visit). 2. Having tests of memory, attention, concentration, and thinking (neuropsychological testing). 3. Having imaging studies of the head including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans. * Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit 2, they will not have brain MRIs or PETs. * No treatments will be provided as part of this research protocol.

Key facts

Study ID
NCT01420939
Run by
National Institute of Nursing Research (NINR)
People needed
19
Starts
2011-07-21
Expected to finish
2013-05-21
Last updated by the study team
2019-12-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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