Institutional Review Board, Hospital for Special Surgery
March 07, 2014
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Apostolos J. Tsiouris, MD
Sumit Niogi, MD
Stephen Lyman, PhD
Joseph Nguyen, MPH
All included subjects will:
1. Be aged ≥15 and ≤50 years old at the time of enrollment;
2. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the first two intervals of the study, as follows:
a. Meets criteria for enrollment in Encounter 1 (within 72 hours)
b. Meets criteria for enrollment in Encounter 2 (within 6-10 days)
3. Be willing to participate in all study activities and provide written informed consent for participation;
4. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors for participation in all parts of the study.
Subjects will be excluded that have:
1. Loss of consciousness (LOC) =15 minutes;
2. Posttraumatic amnesia lasting =24 hr following a recent TBI event;
3. Diagnosis of moderate to severe TBI or GCS <13;
4. Structural brain injury indicated by previous neuroimaging findings;
5. Previous history of moderate to severe TBI;
6. Any previous history of mild TBI within the past 12 months;
7. Previously diagnosed brain white matter disease;
8. History of seizures within the past 10 years;
9. History of self-reported recreational drug usage in past 10 years;
10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
11. Current primary Axis I or II psychiatric disorder
12. History of brain mass
13. History of neurosurgery
14. History of stroke
15. History of dementia
16. Known cognitive dysfunction
17. Known structural brain disease or malformation
18. Current anti-psychotic medication usage, current psychotropic medication usage, or anti-epileptic mediation usage
19. That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;”
20. Contraindications to MRI scanning, including current or suspected pregnancy, claustrophobia, anxiety disorders, and any other conditions, as determined by the investigator, that may impact the subject’s ability to safely undergo MRI examination.