Spinal Cord InjuriesNCT03752749
Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI
A study testing Prednisolone + Acute Intermittent Hypoxia in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab.
Trial summary
The objective of this study is to examine the effects of mild acute intermittent hypoxia (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance in persons with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Prednisolone + Acute Intermittent Hypoxia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 1 Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord lesion at the level of C4 or below.
- Incomplete spinal cord injury ASIA (American Spinal Injury Association) Impairment Scale classification C or D. ASIA C or D classification requires that individuals have detectable motor function below the level of spinal injury and have preserved sensation of the sacral segments S4-S5 (anal sphincter).
- Age between 18 and 65 years.
- Medically stable with medical clearance to participate.
- SCI due to non-progressive etiology.
- More than 6 months since initial SCI. We plan to choose subjects greater that six months post-injury, to ensure minimal confounding effects of spontaneous neurological recovery during the experiments. This will mean that changes in motor performance are due to the interventions associated with the research study.
- Subjects must have active and passive ROM at the ankle from 10 degrees dorsiflexion to 30 degrees plantar flexion, 0 to 120 degrees of knee flexion, 90 degrees of hip flexion, and 10 degrees of hip extension in order to be positioned correctly for motor performance testing.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Presence of severe medical illness, including cardiac disease, uncontrolled high blood pressure, restrictive or obstructive pulmonary disease, significant osteoporosis or history of fracture following SCI, or history of lower limb peripheral nerve injury.
- Individuals with uncontrolled diabetes mellitus, unhealed decubitus ulcers, active heterotopic ossification, rheumatologic disease or inflammatory arthritis, presence of a deep venous thrombosis, cancer, or active infection will be excluded, as these conditions can cause systemic inflammation independent of spinal cord injury.
- Patients may not be receiving any other investigational agents.
- Individuals with tracheostomy, asthma, or recent or current pulmonary infection will be excluded.
- Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
- Subjects will also be excluded if they are currently taking NSAIDs, steroids, or disease-modifying anti-rheumatic drugs (DMARDs). Participation is allowed if the subject and his/her physician agree to suspend all NSAIDs for a minimum of a 14-day washout period prior to study evaluation and for the duration of the study. Individuals taking oral steroids, DMARDs will be excluded from the study due to the potential risks of abruptly discontinuing these agents.
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- Individuals will be excluded if they have a history of severe adverse reaction or allergic response to prednisolone in the past, history of stomach or intestinal ulcers, bleeding problems, chronic kidney disease, drink more than 3 alcoholic beverages per day, or are currently taking blood thinners. Excluding these individuals will limit the potential for having an adverse reaction to the anti-inflammatory administered in the study.
- Individuals receiving intrathecal baclofen will be excluded. Individuals prescribed medications other than intrathecal baclofen for alleviation of spastic motor behaviors will be excluded unless both the subject and his/her physician agree to cease all such medications for a 14-day minimum washout period prior to participation and for the duration of the study.
- Individuals will be excluded if they are taking antifungal ointments, estradiols or estrogens, rifampin, phenytoin, barbiturates or bupropion as these drugs can potential interact with prednisolone. See "concomitant medications" section below.
About this study
The objective of this study is to examine the effects of mild acute intermittent hypoxia (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance in persons with spinal cord injury (SCI).
- Conditions
- Spinal Cord Injuries
- Being tested
- Prednisolone + Acute Intermittent Hypoxia, Placebo + Acute Intermittent Hypoxia
- 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.
Prednisolone + Acute Intermittent HypoxiaOther
Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia
Placebo + Acute Intermittent HypoxiaOther
Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone + Acute Intermittent Hypoxia | Experimental | Not described Receives: Other: Prednisolone + Acute Intermittent Hypoxia |
| Placebo + Acute Intermittent Hypoxia | Placebo comparator | Not described Receives: Other: Placebo + Acute Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Ankle Plantar Flexion strength
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Dec 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zev Rymer, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752749
- Sponsor's protocol ID
- STU00103487
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandhu MS, Gray E, Kocherginsky M, Jayaraman A, Mitchell GS, Rymer WZ. Prednisolone Pretreatment Enhances Intermittent Hypoxia-Induced Plasticity in Persons With Chronic Incomplete Spinal Cord Injury. Neurorehabil Neural Repair. 2019 Nov;33(11):911-921. doi: 10.1177/1545968319872992. Epub 2019 Sep 15.
PubMed 31524075
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI
- ClinicalTrials.gov ID
- NCT03752749
- Acronym / sponsor ID
- STU00103487
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 26 Nov 2018 (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.
The objective of this study is to examine the effects of mild acute intermittent hypoxia (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance in persons with spinal cord injury (SCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone + Acute Intermittent Hypoxia | Experimental | Other: Prednisolone + Acute Intermittent Hypoxia |
| Placebo + Acute Intermittent Hypoxia | Placebo comparator | Other: Placebo + Acute Intermittent Hypoxia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Spinal cord lesion at the level of C4 or below.
- Incomplete spinal cord injury ASIA (American Spinal Injury Association) Impairment Scale classification C or D. ASIA C or D classification requires that individuals have detectable motor function below the level of spinal injury and have preserved sensation of the sacral segments S4-S5 (anal sphincter).
- Age between 18 and 65 years.
- Medically stable with medical clearance to participate.
- SCI due to non-progressive etiology.
Key exclusion criteria (9 listed)
- Presence of severe medical illness, including cardiac disease, uncontrolled high blood pressure, restrictive or obstructive pulmonary disease, significant osteoporosis or history of fracture following SCI, or history of lower limb peripheral nerve injury.
- Individuals with uncontrolled diabetes mellitus, unhealed decubitus ulcers, active heterotopic ossification, rheumatologic disease or inflammatory arthritis, presence of a deep venous thrombosis, cancer, or active infection will be excluded, as these conditions can cause systemic inflammation independent of spinal cord injury.
- Patients may not be receiving any other investigational agents.
- Individuals with tracheostomy, asthma, or recent or current pulmonary infection will be excluded.
- Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
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 |
|---|---|---|
| Prednisolone + Acute Intermittent HypoxiaAdministration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia | Other | Prednisolone + Acute Intermittent Hypoxia |
| Placebo + Acute Intermittent HypoxiaAdministration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia | Other | Placebo + Acute Intermittent Hypoxia |
Primary outcome
Isometric Ankle Plantar Flexion strength
Time frame: 60 minutes
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 Nov 2018.
- Derived from this study: PubMed 31524075Sandhu MS, Gray E, Kocherginsky M, Jayaraman A, Mitchell GS, Rymer WZ. Prednisolone Pretreatment Enhances Intermittent Hypoxia-Induced Plasticity in Persons With Chronic Incomplete Spinal Cord Injury. Neurorehabil Neural Repair. 2019 Nov;33(11):911-921. doi: 10.1177/1545968319872992. Epub 2019 Sep 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone + Acute Intermittent Hypoxia in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab.
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 8 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Isometric Ankle Plantar Flexion strength (time frame: 60 minutes). 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 NCT03752749, 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 Nov 2018.