Evaluating hyperbaric oxygen therapy for traumatic brain injury
A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase
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 type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06816199 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with a documented history of traumatic brain injury and specific imaging signs of injury.
Not a fit: Patients with severe coagulation disorders, pregnancy, or previous spinal cord injuries may not benefit from this study.
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 performed: While hyperbaric oxygen therapy has been explored in various contexts, this specific observational approach to TBI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18\~90 years old 2. Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators: 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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.