Spinal Cord InjuriesNCT05183113
Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI
A study testing Acute Intermittent Hypoxia in people with Spinal Cord Injuries, run by Northwestern University at 1 site in United States.
Trial summary
This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord injury and uninjured controls will enable characterization of changes in neurovascular physiology caused by this… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acute Intermittent Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants must meet the following inclusion criteria:
- Between the ages of 18-60 years
- Safe to be scanned using MRI
- Able to communicate in English
- Ability to sign informed consent
- In addition, the participants recruited with SCI must meet the following criteria:
Show all 11Show fewer
- History of a traumatic spinal cord injury, inclusive of levels C2-T1
- At least 6 months since onset of spinal cord injury
- Cause of the spinal cord injury was non-progressive
- Ability to complete and comply with information within the informed consent
- Ability to close and open at least one hand without assistance
Who cannot join
- MRI contraindications as indicated on MRI safety screening form
- Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
- Women who are currently pregnant, nursing, or planning on becoming pregnant
- Individuals with severe claustrophobia
- Subjects unwilling or unable to give written informed consent in English
- Prisoners
Show all 14Show fewer
- Frequent smokers (greater than 5 cigarettes per day)
- Blood pressure greater than 160/110 or less than 85/55.
- Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study.
- Diagnosis of any of the following comorbid conditions: congestive heart failure, cardiac arrhythmias, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction or known carotid/intracerebral artery stenosis, presence of active deep venous thrombosis, or cancer.
- Individuals who utilize mechanical ventilation or have a tracheostomy
- Individuals who utilize an intrathecal baclofen pump
- Orthopedic injury affecting upper extremities
- Currently participating in any other hypoxia related study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurovascular Mechanisms of Intermittent Hypoxia Induced Neural Plasticity
This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord injury and uninjured controls will enable characterization of changes in neurovascular physiology caused by this promising new therapy.
Read the detailed description
Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant transient improvements in respiratory function, plantar flexion, locomotor function, and hand dexterity and strength. Although these studies observe some degree of success eliciting plasticity, we lack a framework for systematic optimization of the AIH protocol for individual patients.
Better understanding of what physiological mechanisms drive AIH-induced neural plasticity in humans will directly inform the development of AIH as an effective treatment option in chronic SCI. This study applies magnetic resonance imaging (MRI) to test how AIH influences vascular and neural properties of the brain and spinal cord.
Individuals with SCI and uninjured participants will be recruited to undergo two MRI scan sessions on one day. In between these scan sessions, participants will undergo a single 30-minute session of AIH. In each scan session, functional MRI will assess AIH-induced changes in neural activation patterns during motor tasks (unilateral isometric hand grasping tasks) and vascular reactivity to breath hold tasks (transient hypocapnia to induce vasodilation). Additional structural scans will be acquired to aid in image analysis.
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute Intermittent Hypoxia
- Keywords
- Spinal Cord Injury, Acute Intermittent Hypoxia, Magnetic Resonance Imaging
- 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 HypoxiaOther
Participants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol.
| Study group | Role | What they receive |
|---|---|---|
| Acute Intermittent Hypoxia | Experimental | Both healthy participants and those with spinal cord injury will receive the acute intermittent hypoxia (AIH) intervention. All participants are imaged pre- and post-AIH intervention, and thus serve as a self-comparison to observe the hypothesized improvement in bilateral hand strength. Receives: Other: Acute Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD fMRI activation in motor cortex during isometric hand grip tasks
Assess AIH-induced changes in %BOLD activation within the left and right motor cortices during unilateral isometric hand grasping tasks targeting submaximal force levels with real-time feedback.
Measured: Immediately before and ~ 1-hour after AIH on the same day
BOLD fMRI vascular reactivity to a breath-hold task
Measurements of breath-hold induced vasodilation (vascular reactivity, in units of %BOLD/mmHg end-tidal CO2) acquired via functional MRI in the brain and spinal cord.
Measured: Immediately before and ~ 1-hour after AIH on the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start20 May 2019
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Molly Bright, Northwestern University
- Investigators
- Molly G Bright, DPhil, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183113
- Sponsor's protocol ID
- SP0051925
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MR imaging data and the associated physiologic data collected during MRI scanning will be shared in an anonymized format. These data will be made available to public through the Open Science Framework (osf.io) or similar public repository.
Publications
Golder FJ, Mitchell GS. Spinal synaptic enhancement with acute intermittent hypoxia improves respiratory function after chronic cervical spinal cord injury. J Neurosci. 2005 Mar 16;25(11):2925-32. doi: 10.1523/JNEUROSCI.0148-05.2005.
PubMed 15772352Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.
PubMed 28972191Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
PubMed 21821826Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
PubMed 24285617Li Y, Lucas-Osma AM, Black S, Bandet MV, Stephens MJ, Vavrek R, Sanelli L, Fenrich KK, Di Narzo AF, Dracheva S, Winship IR, Fouad K, Bennett DJ. Pericytes impair capillary blood flow and motor function after chronic spinal cord injury. Nat Med. 2017 Jun;23(6):733-741. doi: 10.1038/nm.4331. Epub 2017 May 1.
PubMed 28459438
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Mechanisms of Intermittent Hypoxia Induced Neural Plasticity
- ClinicalTrials.gov ID
- NCT05183113
- Acronym / sponsor ID
- SP0051925
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Acute Intermittent Hypoxia, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 10 Jan 2022 (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 uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord injury and uninjured controls will enable characterization of changes in neurovascular physiology caused by this promising new therapy.
Detailed description
Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant transient improvements in respiratory function, plantar flexion, locomotor function, and hand dexterity and strength. Although these studies observe some degree of success eliciting plasticity, we lack a framework for systematic optimization of the AIH protocol for individual patients.
Better understanding of what physiological mechanisms drive AIH-induced neural plasticity in humans will directly inform the development of AIH as an effective treatment option in chronic SCI. This study applies magnetic resonance imaging (MRI) to test how AIH influences vascular and neural properties of the brain and spinal cord.
Individuals with SCI and uninjured participants will be recruited to undergo two MRI scan sessions on one day. In between these scan sessions, participants will undergo a single 30-minute session of AIH. In each scan session, functional MRI will assess AIH-induced changes in neural activation patterns during motor tasks (unilateral isometric hand grasping tasks) and vascular reactivity to breath hold tasks (transient hypocapnia to induce vasodilation). Additional structural scans will be acquired to aid in image analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Intermittent Hypoxia | Experimental | Other: Acute Intermittent HypoxiaBoth healthy participants and those with spinal cord injury will receive the acute intermittent hypoxia (AIH) intervention. All participants are imaged pre- and post-AIH intervention, and thus serve as a self-comparison to observe the hypothesized improvement in bilateral hand strength. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Between the ages of 18-60 years
- Safe to be scanned using MRI
- Able to communicate in English
- Ability to sign informed consent
- History of a traumatic spinal cord injury, inclusive of levels C2-T1
Key exclusion criteria (14 listed)
- MRI contraindications as indicated on MRI safety screening form
- Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
- Women who are currently pregnant, nursing, or planning on becoming pregnant
- Individuals with severe claustrophobia
- Subjects unwilling or unable to give written informed consent in English
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 HypoxiaParticipants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol. | Other | Acute Intermittent Hypoxia |
Primary outcome
BOLD fMRI activation in motor cortex during isometric hand grip tasks
Time frame: Immediately before and ~ 1-hour after AIH on the same day
Assess AIH-induced changes in %BOLD activation within the left and right motor cortices during unilateral isometric hand grasping tasks targeting submaximal force levels with real-time feedback.
BOLD fMRI vascular reactivity to a breath-hold task
Time frame: Immediately before and ~ 1-hour after AIH on the same day
Measurements of breath-hold induced vasodilation (vascular reactivity, in units of %BOLD/mmHg end-tidal CO2) acquired via functional MRI in the brain and spinal cord.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 15772352Golder FJ, Mitchell GS. Spinal synaptic enhancement with acute intermittent hypoxia improves respiratory function after chronic cervical spinal cord injury. J Neurosci. 2005 Mar 16;25(11):2925-32. doi: 10.1523/JNEUROSCI.0148-05.2005.
- Background: PubMed 28972191Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.
- Background: PubMed 21821826Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
- Background: PubMed 24285617Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
- Background: PubMed 28459438Li Y, Lucas-Osma AM, Black S, Bandet MV, Stephens MJ, Vavrek R, Sanelli L, Fenrich KK, Di Narzo AF, Dracheva S, Winship IR, Fouad K, Bennett DJ. Pericytes impair capillary blood flow and motor function after chronic spinal cord injury. Nat Med. 2017 Jun;23(6):733-741. doi: 10.1038/nm.4331. Epub 2017 May 1.
- Individual participant dataSharing planned: Yes. MR imaging data and the associated physiologic data collected during MRI scanning will be shared in an anonymized format. These data will be made available to public through the Open Science Framework (osf.io) or similar public repository.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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. This study is not recruiting at the moment.
Molly G Bright, DPhil principal investigator
Northwestern University
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 in people with Spinal Cord Injuries, run by Northwestern University 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BOLD fMRI activation in motor cortex during isometric hand grip tasks (time frame: Immediately before and ~ 1-hour after AIH on the same day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183113, which also lists 5 linked publications.
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 28 Sep 2023.