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NCT Number: NCT06816199

The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI).

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI, they will answer online or telephone survey questions about their functional independence for 2 years.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Zhihua Zhang, master

CONTACT

[email protected]

+86 13757159433

About this study

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI). This is a multicenter prospective cohort study.

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI during non-acute phrase after injury, they will answer online or telephone survey questions about their functional independence (including cognitive functioning, physical disability, mental status, employment and social activities) for 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18~90 years old
  • Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators:
  • 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

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

Treatment and study plan

Hyperbaric oxygen exposure

Other

Between 1 week and 3 months after the traumatic brain injury, participants will receive hyperbaric oxygen therapy on a 2.0 ATA protocol for 60 minutes once a day, five times a week.

Primary outcomes

  1. Extended Glasgow Outcome Scale,GOSE

    Time frame: 6-month, 12-month and 24-month after injury

    Overall functional outcomes for participants with traumatic brain injury

Secondary outcomes

  1. Function Independent Measure, FIM

    Time frame: 6-month, 12-month and 24-month after injury

    This scale is for non-comatose patients after traumatic brain injury and includes motor and cognitive function ratings

Other outcomes

  1. Rivermead Post Concussion Symptoms Questionnaire,RPQ

    Time frame: 6-month, 12-month and 24-month after injury

    Mainly for mild traumatic brain injury

Study contacts

Contact information is provided by the study sponsor or research team.

Shuyang Li

CONTACT

[email protected]

+8615167169440

Zhihua Zhang

CONTACT

[email protected]

+8613757159433

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First People's Hospital of Hangzhou
  • Fu Xing Hospital, Capital Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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