NCT04372797 - 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)

Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A
Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016.
Collins MW, Kontos AP, Okonkwo DO, Almquist J, Bailes J, Barisa M, Bazarian J, Bloom OJ, Brody DL, Cantu R, Cardenas J, Clugston J, Cohen R, Echemendia R, Elbin RJ, Ellenbogen R, Fonseca J, Gioia G, Guskiewicz K, Heyer R, Hotz G, Iverson GL, Jordan B, Manley G, Maroon J, McAllister T, McCrea M, Mucha A, Pieroth E, Podell K, Pombo M, Shetty T, Sills A, Solomon G, Thomas DG, Valovich McLeod TC, Yates T, Zafonte R
Statements of Agreement From the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015. Neurosurgery. 2016 Dec;79(6):912-929. doi: 10.1227/NEU.0000000000001447.
Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A
The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug.
Kontos, A
P. and M.W. Collins, Concussion: A clinical profile approach to assessment and treatment. 2018, Washington, DC: American Psychological Association Books
Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP
A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.

Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)

Details for clinical trial NCT04372797

Clinical trial NCT04372797 - References