Spinal Cord InjuryPhase 1NCT01272336
Study Effects of Intermittent Hypoxia on Restoring Hand Function Following SCI
A Phase 1 study testing Acute Intermittent Hypoxia (AIH) in people with Spinal Cord Injury, run by Emory University at 1 site in United States.
Trial summary
The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. 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 (AIH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2015
- 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
- age 18 and 65 years
- medical clearance to participate
- lesion below the 5th cervical spinous process (C5) and above the first thoracic spinous process (T1) with non-progressive etiology
- classified as motor-incomplete injury greater than 12 months
- independent breathing
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 acute intermittent hypoxia on pregnant women and fetus
- Concomitant acquired brain injury
- History of seizures, brain injury, and/or epilepsy
- Diagnosed with obstructive sleep apnea
- Undergoing concurrent physical therapy
Show all 9Show fewer
- Any contraindications to EMG testing procedures (skin sensitivity)
- Any contraindications to passive movement of the limbs
- Score of < 24 on Mini-Mental Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Center for Rehabilitation Medicine
Atlanta, Georgia, 30322
About this study
Official title: Intermittent Hypoxia Promotes Restoration of Hand Function Following SCI
The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).
Read the detailed description
The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).
This idea stems from animal studies on respiration, in which investigators have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections within the spinal cord by a mechanism known as respiratory long-term facilitation. Exposure to mild hypoxia triggers oxygen sensors in the nervous system resulting in a cascade of events, including increased production of key proteins and, increased sensitivity of spinal cord circuitry necessary for improved respiration.
Because previous work using animal models has shown that similar events occur along non-respiratory pathways, the investigators propose to investigate whether a comparable dosing scheme of daily, mild intermittent hypoxia can positively affect upper limb function in persons with cervical SCI.
First, the investigators hypothesize that daily exposure of intermittent hypoxia training (7 consecutive days) will result in a sustained improvement in rat forelimb function that is dose-dependent. To test this hypothesis, the investigators will quantify the effects of variations in the number of intermittent hypoxia episodes on forelimb function in cervical spinal injured rats.
Second, the investigators hypothesize that daily exposure of intermittent hypoxia training will improve hand function in persons with cervical spinal injury. To test this hypothesis, the investigators will quantify the effect of mild intermittent hypoxia exposure, using a protocol derived from the animal model, on volitional grip strength and grasp function in persons with cervical SCI.
The effects of mild intermittent hypoxia, known to increase spinal motor activity, will be assessed as a possible therapeutic intervention to promote functionally useful hand recovery. Results from this study will be valuable for identifying novel strategies to control spinal neuron excitability and for improving motor function in persons with spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Acute Intermittent Hypoxia (AIH), SHAM-Intermittent Room Air
- Keywords
- spinal cord injury, low oxygen, strength, motor control
- 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)Drug
Also called Hypoxia air mixture
Participants will breath intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.09±0.02 (hypoxia) air for 15 minutes.Participants will receive treatment for up to seven visits.
SHAM-Intermittent Room AirOther
Also called Room air mixture
This is a sham intervention to the AIH intervention. Participants will breath intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.21±0.02 (normoxia). Participants will receive treatment for up to seven visits.
| Study group | Role | What they receive |
|---|---|---|
| AIH/Sham | Active comparator | Subjects with chronic, motor-incomplete SCI receive AIH and then SHAM Receives: Drug: Acute Intermittent Hypoxia (AIH); Other: SHAM-Intermittent Room Air |
| Sham/AIH | Active comparator | Subjects with chronic, motor-incomplete SCI receive SHAM and then AIH Receives: Drug: Acute Intermittent Hypoxia (AIH); Other: SHAM-Intermittent Room Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grasp
Measured: 1 week
Secondary outcomes (1)
Grip strength
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 completionAug 2013
- Study completionOct 2015
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan, University of Wisconsin, Madison
- 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
- NCT01272336
- Sponsor's protocol ID
- IRB00035986
- Other IDs
- 163907
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2011
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Trumbower 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 28972191
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia Promotes Restoration of Hand Function Following SCI
- ClinicalTrials.gov ID
- NCT01272336
- Acronym / sponsor ID
- IRB00035986
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, low oxygen, strength, motor control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of Saskatchewan, University of Wisconsin, Madison
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2015 (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 examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).
Detailed description
The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).
This idea stems from animal studies on respiration, in which investigators have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections within the spinal cord by a mechanism known as respiratory long-term facilitation. Exposure to mild hypoxia triggers oxygen sensors in the nervous system resulting in a cascade of events, including increased production of key proteins and, increased sensitivity of spinal cord circuitry necessary for improved respiration.
Because previous work using animal models has shown that similar events occur along non-respiratory pathways, the investigators propose to investigate whether a comparable dosing scheme of daily, mild intermittent hypoxia can positively affect upper limb function in persons with cervical SCI.
First, the investigators hypothesize that daily exposure of intermittent hypoxia training (7 consecutive days) will result in a sustained improvement in rat forelimb function that is dose-dependent. To test this hypothesis, the investigators will quantify the effects of variations in the number of intermittent hypoxia episodes on forelimb function in cervical spinal injured rats.
Second, the investigators hypothesize that daily exposure of intermittent hypoxia training will improve hand function in persons with cervical spinal injury. To test this hypothesis, the investigators will quantify the effect of mild intermittent hypoxia exposure, using a protocol derived from the animal model, on volitional grip strength and grasp function in persons with cervical SCI.
The effects of mild intermittent hypoxia, known to increase spinal motor activity, will be assessed as a possible therapeutic intervention to promote functionally useful hand recovery. Results from this study will be valuable for identifying novel strategies to control spinal neuron excitability and for improving motor function in persons with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIH/Sham | Active comparator | Drug: Acute Intermittent Hypoxia (AIH), Other: SHAM-Intermittent Room AirSubjects with chronic, motor-incomplete SCI receive AIH and then SHAM |
| Sham/AIH | Active comparator | Drug: Acute Intermittent Hypoxia (AIH), Other: SHAM-Intermittent Room AirSubjects with chronic, motor-incomplete SCI receive SHAM and then AIH |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 and 65 years
- medical clearance to participate
- lesion below the 5th cervical spinous process (C5) and above the first thoracic spinous process (T1) with non-progressive etiology
- classified as motor-incomplete injury greater than 12 months
- independent breathing
Key exclusion criteria (9 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 acute intermittent hypoxia on pregnant women and fetus
- Concomitant acquired brain injury
- History of seizures, brain injury, and/or epilepsy
- Diagnosed with obstructive sleep apnea
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)Also: Hypoxia air mixtureParticipants will breath intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.09±0.02 (hypoxia) air for 15 minutes.Participants will receive treatment for up to seven visits. | Drug | AIH/Sham, Sham/AIH |
| SHAM-Intermittent Room AirAlso: Room air mixtureThis is a sham intervention to the AIH intervention. Participants will breath intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.21±0.02 (normoxia). Participants will receive treatment for up to seven visits. | Other | AIH/Sham, Sham/AIH |
Primary outcome
Hand grasp
Time frame: 1 week
1 secondary outcome
Grip strength
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 26 Jan 2016.
- Derived from this study: 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.
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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
1 site 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 (AIH) in people with Spinal Cord Injury, run by Emory 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 5 inclusion and 9 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 26 Jan 2016. 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.
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?
Hand grasp (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 NCT01272336, 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 26 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.