drugset / Trial / NCT01847755

Hyperbaric Treatment of Traumatic Brain Injury (TBI)

NCT01847755

Phase 1/2 Completed 18 enrolled Barry Miskin, MD Jupiter Medical Center · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to test the hypothesis that patients with Traumatic Brain Injury (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement is evidenced by increase in number of pixels on SPECT Scan and increased brain metabolism. Improvement may also be identified via cognitive assessments administered by Jupiter Medical Center Research Department.

Timeline

Start
2013-04
Primary completion
2020-12
Completion
2020-12

Publications

  • Background Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Facts for Physicians about Mild Traumatic Brain Injury (2011, CS109152) Improvement in cerebral metabolism in chronic brain injury after hyperbaric oxygen therapy. International Journal of Neuroscience, 112(2), 119-131.. Harch, P. G., Andrews, S. R., Fogarty, E. F., Amen, D., Pezzullo, J. C., Lucarini, J., and Van Meter, K. W. (2012). A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. Journal of Neurotrauma, 29(1), 168-185. Harch, P. G., Kriedt, C., Van Meter, K. W., and Sutherland, R. J. (2007). Hyperbaric Oxygen Therapy in Global Cerebral Ischemia/Anoxia and Coma, in: Chapter 18, Textbook of Hyperbaric Medicine, 4th revised ed. K.K. Jain (ed.) Hogrefe and Huber Publishers: Seattle, pps. 223-261

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxygen Other / unclassified