Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Evaluating hyperbaric oxygen therapy for traumatic brain injury

Official title: A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06816199 · Data updated 2026-11-12

This study is testing if hyperbaric oxygen therapy is safe and helps adults with traumatic brain injury improve their daily functioning and social activities over two years.

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment300 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedFebruary 10, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2030
Registry record updatedNovember 4, 2026
Trial IDNCT06816199 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 90 with a documented history of traumatic brain injury and specific imaging signs of injury.

Probably not a fit

Patients with severe coagulation disorders, pregnancy, or previous spinal cord injuries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and long-term effects of hyperbaric oxygen therapy in adults over 18 with traumatic brain injury (TBI). Participants will be monitored for their functional independence and ability to engage in social activities over a two-year period, regardless of whether they have previously received hyperbaric oxygen therapy. The study will involve online or telephone surveys to gather data on cognitive functioning, physical disability, mental status, employment, and social activities.

Why it matters

Potential benefit: If successful, this study could improve the quality of life and independence for patients recovering from traumatic brain injury.

How similar studies have gone: While hyperbaric oxygen therapy has been explored in various contexts, this specific observational approach to TBI is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age 18\~90 years old
2. Patients with traumatic brain injury admitted to the rehabilitation department who met the following inclusion criteria:

1\) Clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presence of at least one of the following imaging signs on cranial CT or MRI: Traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed informed consent, and those who were judged by the investigator to be eligible for enrollment.

Exclusion Criteria:

1. Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury;
2. Severe coagulation disorders;
3. Pregnancy status;
4. Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.

Where it's running

  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

  • Principal investigator: Zhihua Zhang — Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine
  • Study coordinator: Zhihua Zhang
  • Email: 2511097@zju.edu.cn
  • Phone: +8613757159433

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.