Status:
COMPLETED
Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
Center for Neuroscience and Regenerative Medicine (CNRM)
Henry M. Jackson Foundation for the Advancement of Military Medicine
Conditions:
Adult
Traumatic Brain Injury
Eligibility:
All Genders
18-44 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatme...
Detailed Description
Objectives: We will: 1) compare performance of healthy volunteers and ambulatory adults with traumatic brain injury (TBI) on a range of motor, neurobehavioral and brain imaging outcomes; and 2) evalua...
Eligibility Criteria
Inclusion
- INLCUSION CRITERIA:
- Inclusion criteria for all subjects (healthy volunteers and those with TBI) include:
- ages 18 - 44, inclusive
- Additional inclusion criteria for those with TBI include:diagnosis of traumatic brain injury
- at least 6 months from initial brain injury
- ability to stand and walk independently and safely without assistance
- sufficient attention and cognition to complete the assessments without a proxy
- capable of providing own consent
- EXCLUSION CRITERIA:
- presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessments or the exercise program, specifically balance problems due to Vestibulopathy, that would affect your ability to perform the assessments or the exercise program
- have any of the following contraindications to having an MRI scan:
- Pregnancy: For any female of childbearing potential who is not pregnant, a pregnancy test will be done.
- A ventriculo-peritoneal shunt
- Have claustrophobia and are not comfortable in small enclosed spaces.
- have metal in your body that would make having an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes). If you have a question about any metal objects being present in your body, you should ask the study doctor.
- Excessive startle reaction to or fear of loud noises
- You are not able to fit in the scanner
- Additional exclusion criteria for those with TBI include:
- Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function.
Exclusion
Key Trial Info
Start Date :
August 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01175993
Start Date
August 24 2011
End Date
February 4 2014
Last Update
November 28 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892