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NCT01420939 · ClinicalTrials.gov registry record
Developing Therapies for Traumatic Brain Injury
A clinical trial, sponsored by National Institute of Nursing Research (NINR).
- Terminated
- Registry status
- 19
- Enrollment target
NCT01420939: Clinical Trial study, sponsored by National Institute of Nursing Research (NINR).
NCT01420939 is a clinical trial that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420939 was terminated before completion, sponsored by National Institute of Nursing Research (NINR).
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
Study Summary
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-07-21 |
| Est. Completion | 2013-05-21 |
Why NCT01420939 stopped before completion
NCT01420939 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01420939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01420939 about?
NCT01420939 is a clinical study titled "Developing Therapies for Traumatic Brain Injury". 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 tr...
What is the current status of trial NCT01420939?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2011-07-21. Estimated completion is 2013-05-21.
Who is sponsoring clinical trial NCT01420939?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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