Last reviewed · How we verify

NCT02089594

Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Status unknown Phase 3 Last updated 16 April 2017
What this trial tests

Phase 3 trial testing Hyperbaric Oxygen in Post-Concussion Syndrome in 59 participants. Status unknown.

Timeline
1 May 2014
Primary endpoint
1 March 2018
1 March 2019

Quick facts

Lead sponsorLouisiana State University Health Sciences Center in New Orleans
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment59
Start date1 May 2014
Primary completion1 March 2018
Estimated completion1 March 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Who can join

Adults 18 to 65, any sex, with Post-Concussion Syndrome or Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial.
    Harch PG, Andrews SR, Rowe CJ, Lischka JR, et al · · 2020 · cited 39× · PMID 32189664 · DOI 10.4103/2045-9912.279978
  2. Detrimental Roles of Hypoxia-Inducible Factor-1α in Severe Hypoxic Brain Diseases.
    Choi YK. · · 2024 · cited 23× · PMID 38674050 · DOI 10.3390/ijms25084465
  3. Hyperbaric oxygen therapy as a potential treatment for post-traumatic stress disorder associated with traumatic brain injury.
    Eve DJ, Steele MR, Sanberg PR, Borlongan CV. · · 2016 · cited 21× · PMID 27799776 · DOI 10.2147/ndt.s110126
  4. Traumatic brain injury and immunological outcomes: the double-edged killer.
    Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037

Verify or expand the search:

Other trials of Hyperbaric Oxygen

Trials testing the same drug.

Other recruiting trials for Post-Concussion Syndrome

Currently open trials in the same condition.

Other Louisiana State University Health Sciences Center in New Orleans trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02089594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing