INCOMPLETE SPINAL CORD INJURY (ASIA D)NCT06906536
Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function
A study testing Acute Intermittent Hypoxia (AIH) in people with INCOMPLETE SPINAL CORD INJURY (ASIA D) and Able Bodied, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- INCOMPLETE SPINAL CORD INJURY (ASIA D), Able Bodied
- What is being tested?
- Acute Intermittent Hypoxia (AIH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 75 years old (the latter to reduce likelihood of heart disease)
- Medically stable with medical clearance from physician to participate
- Motor-incomplete spinal cord injuries at or below C2 and at or above L5
- AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
- More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
- Ability to advance one step overground with or without assistive devices;
Who cannot join
- Severe concurrent illness or pain
- Recurrent autonomic dysreflexia
- History of cardiovascular/pulmonary complications
- Concurrent physical therapy
- Pregnant at time of enrollment or planning to become pregnant
- Untreated painful musculoskeletal dysfunction, fracture or pressure sore
Show all 12Show fewer
- History of seizures or epilepsy
- Recurring headaches
- Concussion within the last six months
- Depression or manic disorder
- Metal implants in the head, or pacemaker
- Aversion to needles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury
The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.
Read the detailed description
The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.
- Being tested
- Acute Intermittent Hypoxia (AIH)
- Keywords
- Acute Intermittent Hypoxia, Spinal cord injury, Force steadiness
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Other
4 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
| Study group | Role | What they receive |
|---|---|---|
| AIH Group | Experimental | Participants will be exposed to 4 consecutive days of acute intermittent hypoxia (AIH): 15, 1.5 min episodes at 9% O2 alternating with 21% O2 at 1 min intervals. Receives: Other: Acute Intermittent Hypoxia (AIH) |
| SHAM Group | No intervention | Participants will be exposed to 4 consecutive days of normoxia: 15, 1.5 min episodes at 21% O2 alternating with 21% O2 at 1 min intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Blood Brain Derived Neurotrophic Factor
Serum blood brain derived neurotrophic factor (pg/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Measured: Baseline, Day 1, Day 3, and Day 4
Change in Serum Serotonin
Serum serotonin (ng/mL) be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Measured: Baseline, Day 1, Day 3, and Day 4
Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope
The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve at 20% and 40% of maximum. We will measure TMS before the start of 4 consecutive days of AIH exposure. We will measure TMS within 24 hours of the final AIH exposure.
Measured: Baseline and Day 4
Change in Force Steadiness
The coefficient of variation of force will be calculated in both plantarflexion and dorsiflexion at 20% and 40% of maximum. We will measure coefficient of variation of force before the start of 4 consecutive days of AIH exposure. We will measure coefficient of variation of force within 24 hours of the final AIH exposure.
Measured: Baseline and Day 4
Change in Central Activation Ratio
We will measure the central activation ratio using supramaximal electrical stimulus over a peripheral nerve during maximum voluntary activation. We will measure the central activation ratio before the start of 4 consecutive days of AIH exposure. We will measure the central activation ratio within 24 hours of the final AIH exposure.
Measured: Baseline and Day 4
Change in hemoglobin mass
Using the optimized carbon monoxide rebreathing procedure we will evaluate hemoglobin concentration, carboxyhemoglobin, and hematocrit to calculate total hemoglobin mass, blood volume, and plasma volume. The optimized carbon monoxide rebreathing procedure will be done prior to the first hypoxia exposure and following the 4th hypoxia exposure.
Measured: Baseline and Day 4
Change in Serum Erythropoetin
Serum erythropoetin (mU/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Measured: Baseline, Day 1, Day 3, and Day 4
Secondary outcomes (3)
Axial damage ratio
Using MRI, we will quantify the axial damage ratio. Prior to participation in the study we will obtain an MRI for quantification of axial damage ratio
Measured: Baseline
6-Minute Walk Test
We will assess the distance walked in 6-minutes. The 6-minute walk test will be completed prior to the first exposure to hypoxia and following the 4th exposure of hypoxia.
Measured: Baseline and Day 4
10-Meter Walk Test
We will assess how long it takes subjects to walk 10 meters. The 10-Meter walk test will be done prior to the first hypoxia exposure, and following the 4th hypoxia exposure.
Measured: Baseline and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INCOMPLETE SPINAL CORD INJURY (ASIA D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver
- Responsible party
- Principal investigator, Andrew Quesada Tan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906536
- Sponsor's protocol ID
- 23-1275
- Other IDs
- 1R03HD115657-01
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06906536
- Acronym / sponsor ID
- 23-1275
- Keywords
- Acute Intermittent Hypoxia, Spinal cord injury, Force steadiness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.
Detailed description
The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIH Group | Experimental | Other: Acute Intermittent Hypoxia (AIH)Participants will be exposed to 4 consecutive days of acute intermittent hypoxia (AIH): 15, 1.5 min episodes at 9% O2 alternating with 21% O2 at 1 min intervals. |
| SHAM Group | No intervention | –Participants will be exposed to 4 consecutive days of normoxia: 15, 1.5 min episodes at 21% O2 alternating with 21% O2 at 1 min intervals. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 75 years old (the latter to reduce likelihood of heart disease)
- Medically stable with medical clearance from physician to participate
- Motor-incomplete spinal cord injuries at or below C2 and at or above L5
- AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
- More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
Key exclusion criteria (12 listed)
- Severe concurrent illness or pain
- Recurrent autonomic dysreflexia
- History of cardiovascular/pulmonary complications
- Concurrent physical therapy
- Pregnant at time of enrollment or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent Hypoxia (AIH)4 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals | Other | AIH Group |
Primary outcome
Change in Serum Blood Brain Derived Neurotrophic Factor
Time frame: Baseline, Day 1, Day 3, and Day 4
Serum blood brain derived neurotrophic factor (pg/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Change in Serum Serotonin
Time frame: Baseline, Day 1, Day 3, and Day 4
Serum serotonin (ng/mL) be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope
Time frame: Baseline and Day 4
The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve at 20% and 40% of maximum. We will measure TMS before the start of 4 consecutive days of AIH exposure. We will measure TMS within 24 hours of the final AIH exposure.
Change in Force Steadiness
Time frame: Baseline and Day 4
The coefficient of variation of force will be calculated in both plantarflexion and dorsiflexion at 20% and 40% of maximum. We will measure coefficient of variation of force before the start of 4 consecutive days of AIH exposure. We will measure coefficient of variation of force within 24 hours of the final AIH exposure.
Change in Central Activation Ratio
Time frame: Baseline and Day 4
We will measure the central activation ratio using supramaximal electrical stimulus over a peripheral nerve during maximum voluntary activation. We will measure the central activation ratio before the start of 4 consecutive days of AIH exposure. We will measure the central activation ratio within 24 hours of the final AIH exposure.
Change in hemoglobin mass
Time frame: Baseline and Day 4
Using the optimized carbon monoxide rebreathing procedure we will evaluate hemoglobin concentration, carboxyhemoglobin, and hematocrit to calculate total hemoglobin mass, blood volume, and plasma volume. The optimized carbon monoxide rebreathing procedure will be done prior to the first hypoxia exposure and following the 4th hypoxia exposure.
Change in Serum Erythropoetin
Time frame: Baseline, Day 1, Day 3, and Day 4
Serum erythropoetin (mU/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
3 secondary outcomes
Axial damage ratio
Time frame: Baseline
6-Minute Walk Test
Time frame: Baseline and Day 4
10-Meter Walk Test
Time frame: Baseline and Day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) in people with INCOMPLETE SPINAL CORD INJURY (ASIA D) and Able Bodied, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Blood Brain Derived Neurotrophic Factor (time frame: Baseline, Day 1, Day 3, and Day 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.