Traumatic brain injury: progress and challenges in prevention, clinical care, and research.
Andrew I R Maas, David K Menon, Geoffrey T Manley...
https://pubmed.ncbi.nlm.nih.gov/36183712Actively Recruiting
Age: 18Years - 90Years
All Genders
ID06816199
A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
F
First People's Hospital of Hangzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and long-term effects of hyperbaric oxygen therapy in adults aged 18 to 90 who have experienced traumatic brain injury (TBI). This observational study aims to understand whether this therapy improves daily independence and social engagement during the non-acute phase after injury. It also seeks to identify any medical problems participants may have when treated with hyperbaric oxygen therapy. Participants who have experienced TBI may or may not have received hyperbaric oxygen therapy as part of their routine medical treatment. The therapy involves treatment at 2.0 ATA for 60 minutes once a day, five times a week, starting between one week and three months after injury. The study includes a group not exposed to hyperbaric oxygen therapy for comparison. During the two-year study, participants will answer online or telephone surveys about their functional independence, including cognitive functioning, physical ability, mental status, employment, and social activities. Researchers will measure outcomes using the Extended Glasgow Outcome Scale at 6, 12, and 24 months after injury, as well as the Function Independent Measure at the same time points. The study includes ongoing monitoring to assess safety and long-term effects of the therapy.
CONDITIONS
Brief Title
The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years old
- Traumatic brain injury caused by trauma such as car accidents, heavy objects, falls, assaults, or explosive injuries
- Glasgow Coma Scale score between 3 and 15 (excluding poisoning, sedation, shock)
- Evidence of traumatic brain injury on cranial CT or MRI, including hemorrhages or brainstem injury
- Good compliance and signed informed consent
- Judged eligible by the investigator
You will not qualify if you...
- Previous or combined spinal cord injury related to the current injury
- Severe coagulation disorders
- Pregnancy
- Any other factors considered a potential risk or interference by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years after injury
Participants with traumatic brain injury are observed, whether or not they undergo hyperbaric oxygen therapy as part of their routine care. Participants complete online or telephone surveys about their functional independence, cognitive functioning, physical disability, mental status, employment, and social activities.
Surveys at 6 months, 12 months, and 24 months after injury
Implementation
Duration - Up to 3 months after injury
Participants receiving hyperbaric oxygen therapy undergo treatment on a 2.0 ATA protocol for 60 minutes once a day, five times a week, between 1 week and 3 months after injury.
5 visits per week during treatment period
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
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Research Team
Z
Zhihua Zhang
S
Shuyang Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Recovery of Consciousness and Functional Outcome in Moderate and Severe Traumatic Brain Injury.
Robert G Kowalski, Flora M Hammond, Alan H Weintraub...
https://pubmed.ncbi.nlm.nih.gov/33646273Functional Outcomes Over the First Year After Moderate to Severe Traumatic Brain Injury in the Prospective, Longitudinal TRACK-TBI Study.
Michael A McCrea, Joseph T Giacino, Jason Barber...
https://pubmed.ncbi.nlm.nih.gov/34228047Identifying the Target Traumatic Brain Injury Population for Hyperbaric Oxygen Therapy.
Samantha Schimmel, Bassel El Sayed, Gavin Lockard...
https://pubmed.ncbi.nlm.nih.gov/37834059