NCT02411227 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cox DJ, Davis M, Singh H, Barbour B, Nidiffer FD, Trudel T, Mourant R, Moncrief R
Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. Mil Med. 2010 Jun;175(6):411-6.
Ortoleva C, Brugger C, Van der Linden M, Walder B
Prediction of driving capacity after traumatic brain injury: a systematic review. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):302-13. doi: 10.1097/HTR.0b013e3182236299. Review.

Evaluation of Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury

Clinical trial NCT02411227 - References