12 Participants NeededMy employer runs this trial

Normobaric Hyperoxia for Spinal Cord Injury

(SpiCoH Trial)

AK
RP
Overseen ByRalisa Pop
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called normobaric hyperoxia, which involves breathing pure oxygen at normal atmospheric pressure, to help individuals with spinal cord injuries breathe better while on a ventilator. The researchers aim to determine if this treatment can improve recovery in patients with traumatic injuries to the neck or upper back. Suitable candidates have a spinal cord injury requiring a ventilator and can follow commands. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that normobaric hyperoxia is safe for spinal cord injury patients?

Research has shown that breathing pure oxygen, known as normobaric hyperoxia, is safe for individuals with spinal cord injuries. Studies on similar treatments, such as hyperbaric oxygen therapy, have also demonstrated safety. These treatments often boost oxygen levels in the body, aiding healing. Previous findings indicate that normobaric hyperoxia is generally well-tolerated, with few serious side effects reported. This suggests that people typically experience no major issues when undergoing this treatment. Although some risks remain, evidence suggests this approach is relatively safe for spinal cord injury patients.12345

Why do researchers think this study treatment might be promising?

Normobaric hyperoxia is unique because it introduces a novel way of treating spinal cord injuries by delivering high levels of oxygen at normal atmospheric pressure. Most traditional treatments for spinal cord injuries, like surgery and rehabilitation, focus on reducing damage and promoting recovery over time. However, normobaric hyperoxia aims to enhance the body's healing process by increasing oxygen availability, potentially reducing inflammation and protecting nerve cells from further damage. Researchers are excited about this approach because it could offer a faster and more efficient recovery path for patients, with fewer side effects compared to more invasive treatments.

What evidence suggests that normobaric hyperoxia might be an effective treatment for spinal cord injury?

Research has shown that breathing extra oxygen at normal pressure, known as normobaric hyperoxia, can greatly enhance oxygen and blood flow to the spinal cord shortly after an injury. This process delivers more oxygen to the injured area, which is crucial for healing. Some evidence also suggests it might reduce nerve pain in patients. However, early data indicates it only slightly aids in preventing further nerve damage after a spinal cord injury. While these findings are promising, more research is needed to confirm these benefits. Participants in this trial will receive normobaric hyperoxia to further investigate these potential advantages.12367

Who Is on the Research Team?

DF

Daryl Fields, MD, PhD

Principal Investigator

University of Florida

CM

Carolina Maciel, MD, MSCR

Principal Investigator

University of Florida

KB

Katharina Busl, MD, MS

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who have had a recent traumatic spinal cord injury in the neck or upper back, need mechanical ventilation, are awake and able to follow commands, and can start treatment within 24 hours of injury. People with brain injuries, certain lung problems, pregnancy, or other serious health issues cannot join.

Inclusion Criteria

Stated willingness to comply with all study procedures for the duration of the study
Need for mechanical ventilation (MV), as determined by the treating physician
I am between 18 and 85 years old.
See 6 more

Exclusion Criteria

Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V
Participation in a concurrent investigational/interventional study (observational studies allowed)
Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

24 hours

Treatment

Intermittent normobaric hyperoxia therapy administered twice daily for 5 consecutive days

5 days
Daily in-person visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Normobaric Hyperoxia

Trial Overview

The study is testing if giving extra oxygen at normal pressure (normobaric hyperoxia) early after spinal cord injury helps recovery. All participants receive this oxygen therapy while on a ventilator. The trial is open-label and takes place at one center.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38780270/

Acute Hyperoxia Improves Spinal Cord Oxygenation and ...

These results suggest that normobaric hyperoxia can significantly improve spinal cord oxygenation and circulatory function in the acute phase ...

Effect of intermittent normobaric hyperoxia for treatment ...

The aim of the study was to investigate the effect of intermittent normobaric hyperoxia (InHO) for treatment of neuropathic pain in patients ...

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days.

Normobaric Oxygen Therapy for Spinal Cord Injury

Preliminary data also indicate that a 1-hour per day treatment with normobaric hyperoxia has only a modest impact on secondary neuronal loss after SCI (i.e. ...

The role of hyperbaric oxygen therapy for treating spinal ...

Clinical data show HBOT reduces pain, anxiety, and improves outcomes. Abstract. Spinal cord injury (SCI) presents formidable challenges, with current ...

Hyperbaric Oxygen Therapy in Traumatic and Non ... - PMC

What are the main findings? HBOT is associated with neurological improvement in selected patients with a spinal cord injury.

Hyperoxia for Spinal Cord Injury

Research has shown that breathing pure oxygen can be safe for people with spinal cord injuries. Studies on a similar treatment, hyperbaric oxygen therapy, ...