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Clinical trialNCT01420939TerminatedObservational

Developing Therapies for Traumatic Brain Injury

SponsorNational Institute of Nursing Research (NINR)Enrollment19Traumatic Brain Injury
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
21 Jul 2011
Primary completion
—
Completion
21 May 2013
Last update posted
12 Dec 2019
Registered enrollment
19
Registry id
NCT01420939
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.