Spinal Cord InjuriesPhase 1/2NCT03774043
Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
A Phase 1/2 study testing Acute Intermittent Hypoxia in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. 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?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jul 2020
- Phase
- Phase 1/2
- 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
- Spinal cord lesion at level of C3 to T1
- Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
- Individuals must be at least 6 months status post injury
- Individuals must be between the ages of 18-70 years inclusive, male or female
- Spinal cord injury must be secondary to a non-progressive etiology
- Individuals must be medically stable.
- Able to comply with protocol/study requirements
- Not currently (>2 weeks) taking any medications for spasticity management.
Who cannot join
- Recent change in the use of narcotic, anti-inflammatory or pain medication
- Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
- History of sleep apnea
- Active participation in another movement research study or therapy program
- Anti-spasticity drug injection less than 3 months, prior to beginning treatment
- Musculoskeletal pain that interferes with participation in study
- Women who are currently, may be or planning on becoming pregnant
Trial locations and contacts
1 site in 1 country.
Sofia Anastasopoulos contact
United States1 site, 1 recruiting
- Recruiting
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Milap S Sandhu, PT, PhD, 312-238-6529, m-sandhu@northwestern.edu
About this study
Official title: Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute Intermittent Hypoxia, Sham 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.
Acute Intermittent HypoxiaOther
Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.
Sham Acute Intermittent HypoxiaOther
Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Single session of Acute Intermittent Hypoxia (AIH) | Experimental | Not described Receives: Other: Acute Intermittent Hypoxia |
| Single session of Sham Acute Intermittent Hypoxia (Sham AIH) | Placebo comparator | Not described Receives: Other: Sham Acute Intermittent Hypoxia |
| Two successive sessions of AIH | Experimental | Not described Receives: Other: Acute Intermittent Hypoxia |
| Two successive sessions of Sham AIH | Placebo comparator | Not described Receives: Other: Sham Acute Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grip strength
A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.
Measured: Baseline, immediately following intervention, and every 30 minutes for 5 hours
Pinch Strength
A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).
Measured: Baseline, immediately following intervention, and every 30 minutes for 5 hours
9 Hole Peg Test
A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.
Measured: Baseline, immediately following intervention, and every 30 minutes for 5 hours
Box and Blocks test
A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds
Measured: Baseline, immediately following intervention, and every 30 minutes for 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startMay 2016
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774043
- Sponsor's protocol ID
- STU00202027
- Status last verified
- Feb 2020
- First submitted
- 11 Dec 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT03774043
- Acronym / sponsor ID
- STU00202027
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 Dec 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.
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single session of Acute Intermittent Hypoxia (AIH) | Experimental | Other: Acute Intermittent Hypoxia |
| Single session of Sham Acute Intermittent Hypoxia (Sham AIH) | Placebo comparator | Other: Sham Acute Intermittent Hypoxia |
| Two successive sessions of AIH | Experimental | Other: Acute Intermittent Hypoxia |
| Two successive sessions of Sham AIH | Placebo comparator | Other: Sham Acute Intermittent Hypoxia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Spinal cord lesion at level of C3 to T1
- Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
- Individuals must be at least 6 months status post injury
- Individuals must be between the ages of 18-70 years inclusive, male or female
- Spinal cord injury must be secondary to a non-progressive etiology
Key exclusion criteria (7 listed)
- Recent change in the use of narcotic, anti-inflammatory or pain medication
- Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
- History of sleep apnea
- Active participation in another movement research study or therapy program
- Anti-spasticity drug injection less than 3 months, prior to beginning treatment
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 HypoxiaPatients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes. | Other | Single session of Acute Intermittent Hypoxia (AIH), Two successive sessions of AIH |
| Sham Acute Intermittent HypoxiaPatients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes. | Other | Single session of Sham Acute Intermittent Hypoxia (Sham AIH), Two successive sessions of Sham AIH |
Primary outcome
Change in grip strength
Time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.
Pinch Strength
Time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).
9 Hole Peg Test
Time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.
Box and Blocks test
Time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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.
Sofia Anastasopoulos contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milap Sandhu, PT, PhD (3122386529, m-sandhu@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grip strength (time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2020.