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RecruitingNCT06816199Updated Feb 10, 2025

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

An observational study in Traumatic Brain Injury, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • traumatic brain injury
  • hyperbaric oxygen
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Non-hyperbaric oxygen exposure group

    Participants with traumatic brain injuries will always be excluded from hyperbaric oxygen therapy

    Other: Hyperbaric oxygen exposure

Interventions

  • OtherHyperbaric 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.

06

What researchers measure

Primary outcomes

  1. Extended Glasgow Outcome Scale,GOSE

    Overall functional outcomes for participants with traumatic brain injury

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

Secondary outcomes

  1. Function Independent Measure, FIM

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

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

Other outcomes

  1. Rivermead Post Concussion Symptoms Questionnaire，RPQ

    Mainly for mild traumatic brain injury

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

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

References and documents

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. PubMed 36183712 ↗
  • 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. PubMed 33646273 ↗
  • 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. PubMed 34228047 ↗
  • 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. PubMed 37834059 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06816199
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
First People's Hospital of Hangzhou, Fu Xing Hospital, Capital Medical University
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Jan 20, 2025
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Feb 10, 2025

Study contacts

Zhihua Zhang
Contact
2511097@zju.edu.cn
+8613757159433
Shuyang Li
Contact
2323035@zju.edu.cn
+8615167169440
Zhihua Zhang
principal investigator · Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine
Sujuan Li
study director · Fu Xing Hospital, Capital Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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