Spinal Cord InjuryPhase 1NCT01272349
Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI
A Phase 1 study testing Acute intermittent hypoxia and Room air in people with Spinal Cord Injury, run by Emory University at 2 sites in United States.
Trial summary
The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Acute intermittent hypoxia and Room air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Nov 2013
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medical clearance to participate
- lesion below C5 and above T12 with non-progressive etiology
- classified as motor-incomplete
- injury greater than 12 months
- ambulatory with minimal assistance
Who cannot join
- Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of cardiac or pulmonary complications)
- Pregnant women because of the unknown affects of AIH on pregnant women and fetus
- History of seizures, brain injury, and/or epilepsy
- Diagnosed with obstructive sleep apnea
- Undergoing concurrent physical therapy
- Any contraindications to EMG testing procedures (skin sensitivity)
- Any contraindications to passive movement of the limbs (e.g., joint immobility, hemodynamic instability)
- Score of < 24 on Mini-Mental Exam
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shepherd Center
Atlanta, Georgia, 30309
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.
The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.
Read the detailed description
: The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.
The investigators initially hypothesize that daily exposure to intermittent hypoxia for 7 consecutive days will improve limb function in rats and in humans with chronic spinal injuries. First, the investigators will compare limb function in spinally-injured rats which receive mild intermittent hypoxia treatment with rats that did not. The investigators will measure grip strength and locomotor abilities in both groups before treatment and for several months after treatment. The investigators will also examine the spinal cords of these rats to look for the key proteins, which are indicators of spinal plasticity. The investigators will use this information to guide the treatment protocols when the investigators compare limb function in spinal-injured persons with and without intermittent hypoxia treatment.
The second hypothesis is that combining intermittent hypoxia with locomotor training will further improve limb function after spinal injury. To test this idea, the investigators will compare limb function in spinally-injured rats which have received combined intermittent hypoxia and treadmill training with rats which only received intermittent hypoxia or locomotor training alone. The investigators will examine key proteins in the spinal cords of these rats to determine whether the combination of hypoxia and training further alters these indicators of plasticity. The investigators will also compare limb function in spinally-injured humans who receive both intermittent hypoxia and locomotor treadmill training with those who receive either treatment alone.
The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.
- Conditions
- Spinal Cord Injury
- Being tested
- Acute intermittent hypoxia, Room air
- Keywords
- spinal cord injury, walking, low oxygen, air, strength
- 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
Also called breathing low oxygen
30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill
Room airOther
Also called breathing room air
30 minutes of breathing room air followed by walking on a body-weight support treadmill
| Study group | Role | What they receive |
|---|---|---|
| Low oxygen | Experimental | Not described Receives: Other: Acute intermittent hypoxia |
| Room Air | Sham comparator | Not described Receives: Other: Room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking performance
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Emory 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Shepherd Center, Atlanta GA, Northwestern University, University of Wisconsin, Madison, University of Saskatchewan
- Responsible party
- Principal investigator, Randy D. Trumbower, Emory University
- Investigators
- Randy D Trumbower, PT, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272349
- Sponsor's protocol ID
- IRB00035986a
- Other IDs
- W81XWH-10-1-0832
- Status last verified
- Nov 2013
- First submitted
- 4 Jan 2011
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayes 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 24285617
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI
- ClinicalTrials.gov ID
- NCT01272349
- Acronym / sponsor ID
- IRB00035986a
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, walking, low oxygen, air, strength
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Shepherd Center, Atlanta GA, Northwestern University, University of Wisconsin, Madison, University of Saskatchewan
- Study start
- Dec 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Jan 2011 (estimated)
- 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 the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.
The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.
Detailed description
: The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.
The investigators initially hypothesize that daily exposure to intermittent hypoxia for 7 consecutive days will improve limb function in rats and in humans with chronic spinal injuries. First, the investigators will compare limb function in spinally-injured rats which receive mild intermittent hypoxia treatment with rats that did not. The investigators will measure grip strength and locomotor abilities in both groups before treatment and for several months after treatment. The investigators will also examine the spinal cords of these rats to look for the key proteins, which are indicators of spinal plasticity. The investigators will use this information to guide the treatment protocols when the investigators compare limb function in spinal-injured persons with and without intermittent hypoxia treatment.
The second hypothesis is that combining intermittent hypoxia with locomotor training will further improve limb function after spinal injury. To test this idea, the investigators will compare limb function in spinally-injured rats which have received combined intermittent hypoxia and treadmill training with rats which only received intermittent hypoxia or locomotor training alone. The investigators will examine key proteins in the spinal cords of these rats to determine whether the combination of hypoxia and training further alters these indicators of plasticity. The investigators will also compare limb function in spinally-injured humans who receive both intermittent hypoxia and locomotor treadmill training with those who receive either treatment alone.
The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low oxygen | Experimental | Other: Acute intermittent hypoxia |
| Room Air | Sham comparator | Other: Room air |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- medical clearance to participate
- lesion below C5 and above T12 with non-progressive etiology
- classified as motor-incomplete
- injury greater than 12 months
- ambulatory with minimal assistance
Key exclusion criteria (8 listed)
- Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of cardiac or pulmonary complications)
- Pregnant women because of the unknown affects of AIH on pregnant women and fetus
- History of seizures, brain injury, and/or epilepsy
- Diagnosed with obstructive sleep apnea
- Undergoing concurrent physical therapy
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 hypoxiaAlso: breathing low oxygen30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill | Other | Low oxygen |
| Room airAlso: breathing room air30 minutes of breathing room air followed by walking on a body-weight support treadmill | Other | Room Air |
Primary outcome
Walking performance
Time frame: 1 Week
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 21 Nov 2013.
- Derived from this study: 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.
- Neuromuscular Control \& Plasticity LaboratoryLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Randy D Trumbower, PT, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acute intermittent hypoxia and Room air in people with Spinal Cord Injury, run by Emory University at 2 sites 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 8 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Walking performance (time frame: 1 Week). 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 NCT01272349, which also lists 1 linked publication.
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 21 Nov 2013.