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:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01939769
Eligibility Criteria:
* INCLUSION CRITERIA:
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* Age 18-45 (inclusive)
* English speaking and writing
* For TBI patients:\<TAB\>
* History of TBI (defined according to the American Congress of Rehabilitation Medicine Criteria: History of having sustained a traumatically induced physiological disruption of brain function at least 2 months before participation)
* Evidence of at least moderate TBI severity. Evidence for intensity of TBI will be any one of the following 3 criteria:
1. GCS greater than or equal to 9 (obtained in Emergency Room and noted in medical record)
2. Post-traumatic amnesia \> 24 hours
3. TBI-related abnormality on neuroimaging (either CT or MRI)
* Documented memory deficit, i.e., a score of 1 standard deviation or more below age-adjusted norm on a recognized clinical test of memory, such as the Wexler Memory Scale, within the last two years.
* Enrollment in Protocol 11-N-0084
* Right-handedness for fMRI participants
EXCLUSION CRITERIA:
* Inability to give informed consent
* History of major neurological or psychiatric illness, e.g., neurodegenerative disorder, stroke, congenital or genetic disorder, currently symptomatic major depressive disorder, schizophrenia
* History of exercise intolerance
* Any finding on examination indicative of cardiac or respiratory compromise
* History of heart disease
* History of pulmonary disease, other than controlled, non-exercise-induced asthma
* History of uncontrolled diabetes
* Resting heart rate \> 100 BPM
* Resting systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 100 mmHg
* Peripheral condition making completion of the exercise protocol impossible, such as severe osteoarthritis or chronic pain
* Pregnancy
* For healthy subjects undergoing MRI:
* Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
* Implanted cardiac pacemaker or auto-defibrillator or pump
* Non-removable body piercing
* Claustrophobia
* Inability to lie supine for two hours
* Any structural brain abnormality, such as tumor or stroke
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01939769
Study Brief:
Protocol Section:
NCT01939769