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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Hyperbaric oxygen exposure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Zhihua Zhang; Phone Number: +8613757159433; Email: 2511097@zju.edu.cn
• Study Contact Backup: Name: Shuyang Li; Phone Number: +8615167169440; Email: 2323035@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Zhihua Zhang, master; Phone Number: +86 13757159433; Email: 2511097@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this observational cohort study, all patients with craniocerebral injuries who satisfy the enrollment requirements and do not meet the exclusion criteria will be included.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-hyperbaric oxygen exposure group; Participants with traumatic brain injuries will always be excluded from hyperbaric oxygen therapy	Other: Hyperbaric oxygen exposure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extended Glasgow Outcome Scale,GOSE	Overall functional outcomes for participants with traumatic brain injury	6-month, 12-month and 24-month after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function Independent Measure, FIM	This scale is for non-comatose patients after traumatic brain injury and includes motor and cognitive function ratings	6-month, 12-month and 24-month after injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rivermead Post Concussion Symptoms Questionnaire，RPQ	Mainly for mild traumatic brain injury	6-month, 12-month and 24-month after injury

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First People's Hospital of Hangzhou; Fu Xing Hospital, Capital Medical University
• Investigators: Principal Investigator: Zhihua Zhang, Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine; Study Director: Sujuan Li, Fu Xing Hospital, Capital Medical University

Publications and helpful links

General Publications

• Maas AIR, Menon DK, Manley GT, Abrams M, Akerlund C, Andelic N, Aries M, Bashford T, Bell MJ, Bodien YG, Brett BL, Buki A, Chesnut RM, Citerio G, Clark D, Clasby B, Cooper DJ, Czeiter E, Czosnyka M, Dams-O'Connor K, De Keyser V, Diaz-Arrastia R, Ercole A, van Essen TA, Falvey E, Ferguson AR, Figaji A, Fitzgerald M, Foreman B, Gantner D, Gao G, Giacino J, Gravesteijn B, Guiza F, Gupta D, Gurnell M, Haagsma JA, Hammond FM, Hawryluk G, Hutchinson P, van der Jagt M, Jain S, Jain S, Jiang JY, Kent H, Kolias A, Kompanje EJO, Lecky F, Lingsma HF, Maegele M, Majdan M, Markowitz A, McCrea M, Meyfroidt G, Mikolic A, Mondello S, Mukherjee P, Nelson D, Nelson LD, Newcombe V, Okonkwo D, Oresic M, Peul W, Pisica D, Polinder S, Ponsford J, Puybasset L, Raj R, Robba C, Roe C, Rosand J, Schueler P, Sharp DJ, Smielewski P, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Temkin N, Tenovuo O, Theadom A, Thomas I, Espin AT, Turgeon AF, Unterberg A, Van Praag D, van Veen E, Verheyden J, Vyvere TV, Wang KKW, Wiegers EJA, Williams WH, Wilson L, Wisniewski SR, Younsi A, Yue JK, Yuh EL, Zeiler FA, Zeldovich M, Zemek R; InTBIR Participants and Investigators. Traumatic brain injury: progress and challenges in prevention, clinical care, and research. Lancet Neurol. 2022 Nov;21(11):1004-1060. doi: 10.1016/S1474-4422(22)00309-X. Epub 2022 Sep 29. Erratum In: Lancet Neurol. 2022 Dec;21(12):e10. doi: 10.1016/S1474-4422(22)00411-2.
• Kowalski RG, Hammond FM, Weintraub AH, Nakase-Richardson R, Zafonte RD, Whyte J, Giacino JT. Recovery of Consciousness and Functional Outcome in Moderate and Severe Traumatic Brain Injury. JAMA Neurol. 2021 May 1;78(5):548-557. doi: 10.1001/jamaneurol.2021.0084.
• McCrea MA, Giacino JT, Barber J, Temkin NR, Nelson LD, Levin HS, Dikmen S, Stein M, Bodien YG, Boase K, Taylor SR, Vassar M, Mukherjee P, Robertson C, Diaz-Arrastia R, Okonkwo DO, Markowitz AJ, Manley GT; TRACK-TBI Investigators; Adeoye O, Badjatia N, Bullock MR, Chesnut R, Corrigan JD, Crawford K, Duhaime AC, Ellenbogen R, Feeser VR, Ferguson AR, Foreman B, Gardner R, Gaudette E, Goldman D, Gonzalez L, Gopinath S, Gullapalli R, Hemphill JC, Hotz G, Jain S, Keene CD, Korley FK, Kramer J, Kreitzer N, Lindsell C, Machamer J, Madden C, Martin A, McAllister T, Merchant R, Ngwenya LB, Noel F, Nolan A, Palacios E, Perl D, Puccio A, Rabinowitz M, Rosand J, Sander A, Satris G, Schnyer D, Seabury S, Sherer M, Toga A, Valadka A, Wang K, Yue JK, Yuh E, Zafonte R. Functional Outcomes Over the First Year After Moderate to Severe Traumatic Brain Injury in the Prospective, Longitudinal TRACK-TBI Study. JAMA Neurol. 2021 Aug 1;78(8):982-992. doi: 10.1001/jamaneurol.2021.2043.
• Schimmel S, El Sayed B, Lockard G, Gordon J, Young I, D'Egidio F, Lee JY, Rodriguez T, Borlongan CV. Identifying the Target Traumatic Brain Injury Population for Hyperbaric Oxygen Therapy. Int J Mol Sci. 2023 Sep 27;24(19):14612. doi: 10.3390/ijms241914612.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: traumatic brain injury; hyperbaric oxygen
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: 2024-1224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No