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SpiCoHEarly Normobaric Hyperoxia for Spinal Cord Injury Treatment

Study Aim

This phase 2 study aims to evaluate the feasibility and preliminary safety of early normobaric hyperoxia therapy for spinal cord injury treatment, focusing on achieving high oxygen concentrations systemically and monitoring four-point end-organ toxicity surveillance.

What is being tested

Normobaric Hyperoxia

Other

Who is being recruted

Signs and Symptoms+1

+ Signs and Symptoms, Respiratory

+ Pathological Conditions, Signs and Symptoms

From 18 to 85 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorUniversity of Florida

Study ContactAndrew KlineMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on treating spinal cord injuries using a method called intermittent normobaric hyperoxia (NBH). NBH involves breathing in pure oxygen (100% FiO2) for a certain period of time, specifically 4.5 hours, twice daily for five consecutive days. The study aims to understand if this treatment can be started early after a spinal cord injury and if it can improve patient outcomes. The research is important because it could potentially offer a new approach to manage spinal cord injuries, which currently lack effective treatments. Participants in this study will undergo NBH therapy in two different schedules, either with a minimum gap of 1.5 hours between sessions (treatment B) or a gap of 10 hours (treatment A). The main goals are to evaluate if it's feasible to administer early NBH therapy, if the therapy can achieve high oxygen concentrations in the body, and to assess its preliminary safety. The study will measure these outcomes by tracking the proportion of participants receiving the first NBH therapy, monitoring oxygen levels in the body, and conducting a four-point end-organ toxicity surveillance to check for any potential side effects.

Official TitleTreating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial

NCT07465302

Principal SponsorUniversity of Florida

Study ContactAndrew KlineMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsHyperoxia

Criteria

9 inclusion criteria required to participate

Provision of signed and dated ICF by the subject or LAR

Stated willingness to comply with all study procedures for the duration of the study

Male or female subjects, aged >= 18 and <= 85 years

Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)

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10 exclusion criteria prevent from participating

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

Known to be pregnant, or with a positive pregnancy test

Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia < 100,000/uL or International Normalized Ratio > 1.5)

Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Normobaric hyperoxia

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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