Spinal Cord InjuriesNCT05513911
Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With Spinal Cord Injury
A study testing Acute Intermittent Hypoxia in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2016to 25 Mar 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Spinal Cord Injury from C3-T4
- Non-progressive spinal cord injury
- More than 6 months since initial Spinal Cord injury
- Ability to understand and willingness to sign written informed consent
Who cannot join
- Presence of any of the following medical conditions: Congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma
- Persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis
- Medical clearance will be required if participant is taking any other investigational agents
- Women who are pregnant or nursing
- Individuals with tracheostomy
- Cannot pursue other research studies which may interfere
Show all 9Show fewer
- Unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury
In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record bicep muscle activations before and after bouts of AIH
Read the detailed description
It has been shown previously that there is an increase in strength in survivors of spinal cord injury after brief bouts of Acute Intermittent Hypoxia. In this study, participants are fitted with a high density EMG electrode on the biceps brachii, and attached to a load cell at the wrist, they are asked to flex and extend their elbow at various levels of intensity. This is performed before and after the 30 minute session of AIH. The investigators hope to identify specific types of motor units of the upper extremity of survivors of spinal cord injury after AIH to help further our understanding of what mechanisms may be causing the known increase in muscle strength post AIH
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute Intermittent Hypoxia
- Keywords
- Acute Intermittent Hypoxia, Motor Unit, Upper Extremity
- 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 AIH
Acute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session
| Study group | Role | What they receive |
|---|---|---|
| Acute intermittent Hypoxia Therapy | Experimental | This group will receive the acute intermittent hypoxia therapy (9% O2) for 30 minutes. Before and after the intervention the participant will perform flexion of the elbow at various levels of intensity Receives: Other: Acute Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Elbow Strength [Newtons]
Recordings of the elbow joint torque are taken while the participant is asked to flex and extend the elbow voluntarily at a maximum level of intensity
Measured: 30 minutes Post intervention
Secondary outcomes (1)
Biceps Brachii Muscle activation [μv]
Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks
Measured: 30 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start3 Feb 2016
- Primary completion8 Nov 2016
- Study completion25 Mar 2019
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 InjuriesStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every participant in this study will receive the intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- William Z Rymer, MD, PhD, Principal investigator, Shirley Ryan AbilityLabMilap Sandhu, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513911
- Sponsor's protocol ID
- STU00201602
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall participant Data will be reported in publications
Publications
Pearcey GEP, Afsharipour B, Holobar A, Sandhu MS, Rymer WZ. Acute intermittent hypoxia increases maximal motor unit discharge rates in people with chronic incomplete spinal cord injury. J Physiol. 2024 Nov;602(21):5699-5711. doi: 10.1113/JP285049. Epub 2024 Jul 26.
PubMed 39058666
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05513911
- Acronym / sponsor ID
- STU00201602
- Conditions
- Spinal Cord Injuries
- Keywords
- Acute Intermittent Hypoxia, Motor Unit, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 24 Aug 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.
In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record bicep muscle activations before and after bouts of AIH
Detailed description
It has been shown previously that there is an increase in strength in survivors of spinal cord injury after brief bouts of Acute Intermittent Hypoxia. In this study, participants are fitted with a high density EMG electrode on the biceps brachii, and attached to a load cell at the wrist, they are asked to flex and extend their elbow at various levels of intensity. This is performed before and after the 30 minute session of AIH. The investigators hope to identify specific types of motor units of the upper extremity of survivors of spinal cord injury after AIH to help further our understanding of what mechanisms may be causing the known increase in muscle strength post AIH
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every participant in this study will receive the intervention
| Arm | Type | Receives |
|---|---|---|
| Acute intermittent Hypoxia Therapy | Experimental | Other: Acute Intermittent HypoxiaThis group will receive the acute intermittent hypoxia therapy (9% O2) for 30 minutes. Before and after the intervention the participant will perform flexion of the elbow at various levels of intensity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of Spinal Cord Injury from C3-T4
- Non-progressive spinal cord injury
- More than 6 months since initial Spinal Cord injury
- Ability to understand and willingness to sign written informed consent
Key exclusion criteria (9 listed)
- Presence of any of the following medical conditions: Congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma
- Persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis
- Medical clearance will be required if participant is taking any other investigational agents
- Women who are pregnant or nursing
- Individuals with tracheostomy
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: AIHAcute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session | Other | Acute intermittent Hypoxia Therapy |
Primary outcome
Maximal Elbow Strength [Newtons]
Time frame: 30 minutes Post intervention
Recordings of the elbow joint torque are taken while the participant is asked to flex and extend the elbow voluntarily at a maximum level of intensity
1 secondary outcome
Biceps Brachii Muscle activation [μv]
Time frame: 30 minutes post intervention
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 24 Aug 2022.
- Derived from this study: PubMed 39058666Pearcey GEP, Afsharipour B, Holobar A, Sandhu MS, Rymer WZ. Acute intermittent hypoxia increases maximal motor unit discharge rates in people with chronic incomplete spinal cord injury. J Physiol. 2024 Nov;602(21):5699-5711. doi: 10.1113/JP285049. Epub 2024 Jul 26.
- Individual participant dataSharing planned: No. Overall participant Data will be reported in publications
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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.
William Z Rymer, MD, PhD principal investigator
Shirley Ryan AbilityLab
Milap Sandhu, 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 in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab 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 4 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 24 Aug 2022. 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?
Maximal Elbow Strength [Newtons] (time frame: 30 minutes Post intervention). 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 NCT05513911, 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 24 Aug 2022.