Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT01175993
Eligibility Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01175993
Study Brief:
Protocol Section:
NCT01175993