Last reviewed · How we verify
NCT00760734
HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Phase 1 trial testing Low pressure hyperbaric oxygen therapy in TBI (Traumatic Brain Injury) in 30 participants. Completed in 1 June 2011.
1 September 2010
Quick facts
| Lead sponsor | Paul G. Harch, M.D. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2008 |
| Primary completion | 1 September 2010 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low pressure hyperbaric oxygen therapy — full drug profile →
- Low pressure hyperbaric oxygen therapy — full drug profile →
Conditions studied
- TBI (Traumatic Brain Injury) — all drugs for TBI (Traumatic Brain Injury) →
- Post Concussion Syndrome — all drugs for Post Concussion Syndrome →
- Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
- Chronic Post Traumatic Stress Disorder — all drugs for Chronic Post Traumatic Stress Disorder →
Sponsor
Paul G. Harch, M.D. — full company profile →
Who can join
Adults 18 to 65, any sex, with TBI (Traumatic Brain Injury) or Post Concussion Syndrome. 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.
-
Psychometric testing
Time frame: 30 days
Sponsor's own description
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Case control study: hyperbaric oxygen treatment of mild traumatic brain injury persistent post-concussion syndrome and post-traumatic stress disorder.
Harch PG, Andrews SR, Fogarty EF, Lucarini J, et al · · 2017 · cited 30× · PMID 29152209 · DOI 10.4103/2045-9912.215745 -
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
Verify or expand the search:
- PubMed search for NCT00760734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for TBI (Traumatic Brain Injury)
Currently open trials in the same condition.
- NCT07103200 — Evaluation of Decision-Making Fatigue After Traumatic Brain Injury · NA · recruiting
- NCT05205174 — Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury · NA · recruiting
- NCT06867666 — Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury · NA · recruiting
- NCT05327829 — Stimulating After Recovery From Traumatic Brain Injury · EARLY_PHASE1 · recruiting
- NCT06467708 — Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00760734 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Paul G. Harch, M.D.
- Last refreshed: 16 April 2017
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/NCT00760734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing