Spinal Cord Injuries (SCI)NCT07583498
Spasticity in SCI Following Acute Intermittent Hypoxia
A study testing Acute Intermittent Hypoxia (AIH) in people with Spinal Cord Injuries (SCI), run by Zev Rymer at 1 site in United States.
Trial summary
This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Acute Intermittent Hypoxia (AIH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18
- Non-progressive spinal Cord injury at least 6 months prior
- Level of injury between C1-C8
- ISNCSCI ASIA classification C or D
- Measurable Spasticity
Who cannot join
- Pre-existing hypoxic pulmonary disease
- Positive Covid-Pneumonia diagnosis within 1 year of visit
- Uncontrolled hypertension >140/90 mmHg
- Individuals who are currently pregnant/nursing or planning on becoming pregnant
- Individuals with a tracheostomy or who utilize mechanical ventilation
- A botulinum toxin injection to upper extremity musculature within the past 3 months
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- Currently taking Baclofen
- Congestive Heart Failure
- Cardiac arrhythmias
- Uncontrolled diabetes mellitus
- Chronic obstructive pulmonary disease
- Emphysema
- Severe Asthma
- Previous myocardial infarction
- Carotid/intracerebral artery stenosis
- Orthopedic injuries or surgeries that impact the ability to use the upper extremity
- History of Epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Alexander Barry, MS, 312-238-1435, abarry@sralab.org
William z Rymer, MD, PhD
About this study
Official title: Does the Administration of Acute Intermittent Hypoxia in Persons With Chronic Spinal Cord Injury Make Spasticity Worse?
This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.
Read the detailed description
In the case of incomplete traumatic spinal cord injury, it is know now that muscular strength improves quickly after AIH administration, and this Increase in voluntary strength lasts from three to six hours. The Increase in strength, coupled with demonstrated improvements in spinal cord neural plasticity, makes AIH administration a potentially valuable new therapeutic intervention. AIH initially acts by releasing serotonin in the central nervous system, enhancing persistent sodium uptake (via the motor neuron soma) and activating voltage-gated calcium channels in motor neuron dendrites. There are also other effects of serotonin on motor neuron excitable channels. One potential complication of hypoxia is linked to the changes in motor neuron excitability in humans with SCI.
These issues may be relevant to our potential work on the Therapeutic efficacy of AIH in persons with incomplete spinal cord injury. In other words, if individuals are highly spastic, it may indicate that their neuronal receptor sites are inaccessible, and increasing spinal cord serotonin levels may not be beneficial.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Acute Intermittent Hypoxia (AIH)
- Keywords
- Hypoxia, Spasticity, Reflex
- Medical subject headings
- Spinal Cord Injuries, Hypoxia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Device
This intervention involves breathing lowered levels of oxygen for 60 seconds, alternating with 60 seconds of room air breathing. Participants will be monitored and observed during the entire session for any changes in vital signs
| Study group | Role | What they receive |
|---|---|---|
| AIH intervention | Experimental | In this Arm, participants will receive the Acute Intermittent Hypoxia Intervention. In this AIH, participants will breath alternating bouts of lowered oxygen and room air (approximately 60 seconds of each) for around 30 minutes. Receives: Device: Acute Intermittent Hypoxia (AIH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reflex indentation threshold
Similar to a tendon tap that a doctor may perform, this study uses an automated tendon tapper to measure the level of indentation needed to elicit a reflex in the bicep muscle. The aim is to observe any changes in reflex threshold following the AIH intervention
Measured: Day 1 of Intervention
Secondary outcomes (2)
Change in Modified Ashworth Scale - Elbow
The modified Ashworth scale is a measure of Spasticity, performed by a trained administrator. This test involves rapidly rotating the participant's arm and feeling the spastic muscle response. This assessment is scored from 0 to 4, with 0 indicating no spasticity, and 4 indicating a fully contracted limb
Measured: Day 1 of intervention
Grip Strength
Using a handheld dynamometer, maximum grip strength of participants will be measured
Measured: Day 1 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start17 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zev Rymer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zev Rymer, Shirley Ryan AbilityLab
- Investigators
- William Z Rymer, MD, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583498
- Sponsor's protocol ID
- STU00225515
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we will provide de-identified study data to researchers. The ICF and Protocol will be uploaded upon completion of study procedures
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Administration of Acute Intermittent Hypoxia in Persons With Chronic Spinal Cord Injury Make Spasticity Worse?
- ClinicalTrials.gov ID
- NCT07583498
- Acronym / sponsor ID
- STU00225515
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Hypoxia, Spasticity, Reflex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zev RymerUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 May 2026 (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.
This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.
Detailed description
In the case of incomplete traumatic spinal cord injury, it is know now that muscular strength improves quickly after AIH administration, and this Increase in voluntary strength lasts from three to six hours. The Increase in strength, coupled with demonstrated improvements in spinal cord neural plasticity, makes AIH administration a potentially valuable new therapeutic intervention. AIH initially acts by releasing serotonin in the central nervous system, enhancing persistent sodium uptake (via the motor neuron soma) and activating voltage-gated calcium channels in motor neuron dendrites. There are also other effects of serotonin on motor neuron excitable channels. One potential complication of hypoxia is linked to the changes in motor neuron excitability in humans with SCI.
These issues may be relevant to our potential work on the Therapeutic efficacy of AIH in persons with incomplete spinal cord injury. In other words, if individuals are highly spastic, it may indicate that their neuronal receptor sites are inaccessible, and increasing spinal cord serotonin levels may not be beneficial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIH intervention | Experimental | Device: Acute Intermittent Hypoxia (AIH)In this Arm, participants will receive the Acute Intermittent Hypoxia Intervention. In this AIH, participants will breath alternating bouts of lowered oxygen and room air (approximately 60 seconds of each) for around 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18
- Non-progressive spinal Cord injury at least 6 months prior
- Level of injury between C1-C8
- ISNCSCI ASIA classification C or D
- Measurable Spasticity
Key exclusion criteria (17 listed)
- Pre-existing hypoxic pulmonary disease
- Positive Covid-Pneumonia diagnosis within 1 year of visit
- Uncontrolled hypertension >140/90 mmHg
- Individuals who are currently pregnant/nursing or planning on becoming pregnant
- Individuals with a tracheostomy or who utilize mechanical ventilation
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)This intervention involves breathing lowered levels of oxygen for 60 seconds, alternating with 60 seconds of room air breathing. Participants will be monitored and observed during the entire session for any changes in vital signs | Device | AIH intervention |
Primary outcome
Change in reflex indentation threshold
Time frame: Day 1 of Intervention
Similar to a tendon tap that a doctor may perform, this study uses an automated tendon tapper to measure the level of indentation needed to elicit a reflex in the bicep muscle. The aim is to observe any changes in reflex threshold following the AIH intervention
2 secondary outcomes
Change in Modified Ashworth Scale - Elbow
Time frame: Day 1 of intervention
Grip Strength
Time frame: Day 1 of intervention
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 13 May 2026.
- Individual participant dataSharing planned: Yes. Upon request, we will provide de-identified study data to researchers. The ICF and Protocol will be uploaded upon completion of study procedures
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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.
William Z Rymer, MD, PhD principal investigator
Shirley Ryan AbilityLab
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 Spinal Cord Injuries (SCI), run by Zev Rymer 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
Contact William Z Rymer, MD, PhD (312-238-3919, w-rymer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reflex indentation threshold (time frame: Day 1 of Intervention). 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 13 May 2026.