David X Cifu1, William C Walker, Steven L West, Brett B Hart, Laura Manning Franke, Adam Sima, Carolyn W Graham, William Carne. 1. Physical Medicine and Rehabilitation Program Office, Department of Veterans Affairs, Washington, DC; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA; Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, VA; Center for Rehabilitation Sciences and Engineering, Richmond, VA.
Abstract
OBJECTIVE:Mild traumatic brain injury (mTBI) and postconcussion syndrome (PCS) are common among military combatants. Hyperbaric oxygen (HBO2 ) is a proposed treatment for these conditions, but it has not been rigorously studied. The objective of this study was to determine the effects of HBO2 by 3 months post compression at 2 commonly employed dosing levels to treat PCS; whether specific subgroups may have benefited; and if no overall effect was found, whether benefit is masked by other conditions. METHODS: This randomized, double-blind, sham-controlled study was conducted at the Naval Air Station in Pensacola, Florida on 61 male Marines with a history of mTBI and PCS. Intervention consisted of 40 once daily 60-minute hyperbaric chamber compressions at 2.0 atmospheres absolute (ATA) at 1 of 3 randomly preassigned oxygen fractions, resulting in respective blinded groups with an oxygen-breathing exposure equivalent to (1) surface air (sham), (2) 100% oxygen at 1.5ATA, or (3) 100% oxygen at 2.0ATA. The main outcome measure was the Rivermead Post-Concussion Questionnaire-16 (RPQ-16) collected before compressions and at 2 later points. RESULTS: The interaction of time by intervention group was not significant for improvement on the RPQ-16. Nor was there evidence of efficacy on the RPQ-16 for any subgroup. No significant time by intervention interaction was found for any functional, cognitive, or psychomotor secondary outcome measure at an unadjusted 0.05 significance level. INTERPRETATION: Using a randomized control trial design and analysis including a sham, results showed no evidence of efficacy by 3 months post-compression to treat the symptomatic, cognitive, or behavioral sequelae of PCS after combat-related mTBI.
RCT Entities:
OBJECTIVE: Mild traumatic brain injury (mTBI) and postconcussion syndrome (PCS) are common among military combatants. Hyperbaric oxygen (HBO2 ) is a proposed treatment for these conditions, but it has not been rigorously studied. The objective of this study was to determine the effects of HBO2 by 3 months post compression at 2 commonly employed dosing levels to treat PCS; whether specific subgroups may have benefited; and if no overall effect was found, whether benefit is masked by other conditions. METHODS: This randomized, double-blind, sham-controlled study was conducted at the Naval Air Station in Pensacola, Florida on 61 male Marines with a history of mTBI and PCS. Intervention consisted of 40 once daily 60-minute hyperbaric chamber compressions at 2.0 atmospheres absolute (ATA) at 1 of 3 randomly preassigned oxygen fractions, resulting in respective blinded groups with an oxygen-breathing exposure equivalent to (1) surface air (sham), (2) 100% oxygen at 1.5ATA, or (3) 100% oxygen at 2.0ATA. The main outcome measure was the Rivermead Post-Concussion Questionnaire-16 (RPQ-16) collected before compressions and at 2 later points. RESULTS: The interaction of time by intervention group was not significant for improvement on the RPQ-16. Nor was there evidence of efficacy on the RPQ-16 for any subgroup. No significant time by intervention interaction was found for any functional, cognitive, or psychomotor secondary outcome measure at an unadjusted 0.05 significance level. INTERPRETATION: Using a randomized control trial design and analysis including a sham, results showed no evidence of efficacy by 3 months post-compression to treat the symptomatic, cognitive, or behavioral sequelae of PCS after combat-related mTBI.
Authors: Pashtun Shahim; Henrik Zetterberg; Joel Simrén; Nicholas J Ashton; Gina Norato; Michael Schöll; Yelverton Tegner; Ramon Diaz-Arrastia; Kaj Blennow Journal: Neurology Date: 2022-06-02 Impact factor: 11.800
Authors: Pashtun Shahim; Adam Politis; Andre van der Merwe; Brian Moore; Yi-Yu Chou; Dzung L Pham; John A Butman; Ramon Diaz-Arrastia; Jessica M Gill; David L Brody; Henrik Zetterberg; Kaj Blennow; Leighton Chan Journal: Neurology Date: 2020-07-08 Impact factor: 9.910