search
Back to results

Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Hypoxia, Hyperoxia, Reflex, Sensation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Individuals with traumatic SCI with onset ≥3 months prior,
  2. Between 18 - 65 yr old,
  3. ASIA Impairment Scale at discharge classified as A, B or C,
  4. Injury level between C5 and T10,
  5. Able to give informed, written consent.

Exclusion Criteria:

  1. Frequent uncontrolled autonomic dysreflexia,
  2. Uncontrolled high blood pressure,
  3. Cardiac or cardiovascular disease,
  4. Cancer,
  5. Active urinary tract infection,
  6. Active pressure sores,
  7. Signs of deep vein thrombosis in the legs,
  8. Severe swelling of the feet and/or legs,
  9. Severe cognitive impairment,
  10. Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
  11. Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
  12. Pregnancy.

Sites / Locations

  • University of Alberta, Clinical Sciences BldgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyperoxia followed by room air

Room air followed by hyperoxia

Arm Description

Group 1 will receive oxygen (99%) in Phase 1, and room air (placebo) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. In Phase 2, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. Both high oxygen and room air will be delivered through a face mask. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure. In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.

Group 2 will receive room air (placebo) in Phase 1, and oxygen (99%) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. In Phase 2, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. Both high oxygen and room air will be delivered through a face mask approved by Health Canada. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure.In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.

Outcomes

Primary Outcome Measures

Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.

Secondary Outcome Measures

Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).

Full Information

First Posted
July 6, 2022
Last Updated
July 26, 2023
Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT05467215
Brief Title
Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
Official Title
Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).
Detailed Description
This proof-of-principle study will include a small number of participants with subacute or chronic (>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen. Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects. If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Hypoxia, Hyperoxia, Reflex, Sensation

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Prospective, double-blind, randomized crossover design
Masking
ParticipantOutcomes Assessor
Masking Description
The participants with SCI will be masked. The experimenter collecting the sensory data and the experimenter analyzing the reflex data will be masked to the oxygen/air exposure, to avoid bias. The participant and the experimenter will be unmasked once all data collection has been completed for the participant.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperoxia followed by room air
Arm Type
Experimental
Arm Description
Group 1 will receive oxygen (99%) in Phase 1, and room air (placebo) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. In Phase 2, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. Both high oxygen and room air will be delivered through a face mask. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure. In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.
Arm Title
Room air followed by hyperoxia
Arm Type
Placebo Comparator
Arm Description
Group 2 will receive room air (placebo) in Phase 1, and oxygen (99%) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. In Phase 2, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. Both high oxygen and room air will be delivered through a face mask approved by Health Canada. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure.In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.
Intervention Type
Drug
Intervention Name(s)
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
Other Intervention Name(s)
Compressed air from Praxair, DIN# 02014483
Intervention Description
Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.
Primary Outcome Measure Information:
Title
Skin Sensation
Description
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time Frame
Pre-intervention (exposure to high oxygen)
Title
Skin Sensation
Description
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time Frame
Immediately after intervention (exposure to high oxygen)
Title
Skin Sensation
Description
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time Frame
Pre-intervention (exposure to room air)
Title
Skin Sensation
Description
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time Frame
Immediately after intervention (exposure to room air)
Secondary Outcome Measure Information:
Title
Reflex Excitability
Description
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time Frame
Pre-intervention (exposure to high oxygen)
Title
Reflex Excitability
Description
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time Frame
Immediately after intervention (exposure to high oxygen)
Title
Reflex Excitability
Description
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time Frame
Pre-intervention (exposure to room air)
Title
Reflex Excitability
Description
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time Frame
Immediately after intervention (exposure to room air)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals with traumatic SCI with onset ≥3 months prior, Between 18 - 65 yr old, ASIA Impairment Scale at discharge classified as A, B or C, Injury level between C5 and T10, Able to give informed, written consent. Exclusion Criteria: Frequent uncontrolled autonomic dysreflexia, Uncontrolled high blood pressure, Cardiac or cardiovascular disease, Cancer, Active urinary tract infection, Active pressure sores, Signs of deep vein thrombosis in the legs, Severe swelling of the feet and/or legs, Severe cognitive impairment, Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection, Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Barnes, PT
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jaynie Yang, PT, PhD
Phone
7804922894
Email
jaynie@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaynie Yang
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta, Clinical Sciences Bldg
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Barnes
Phone
7804055917
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Jaynie Yang
Phone
7804922894
Email
jaynie@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

We'll reach out to this number within 24 hrs