Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
1 other identifier
interventional
24
1 country
1
Brief 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. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 19, 2020
February 1, 2020
3.8 years
December 11, 2018
February 17, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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).
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.
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
Baseline, immediately following intervention, and every 30 minutes for 5 hours
Study Arms (4)
Single session of Acute Intermittent Hypoxia (AIH)
EXPERIMENTALSingle session of Sham Acute Intermittent Hypoxia (Sham AIH)
PLACEBO COMPARATORTwo successive sessions of AIH
EXPERIMENTALTwo successive sessions of Sham AIH
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 12, 2018
Study Start
May 1, 2016
Primary Completion
March 1, 2020
Study Completion
July 1, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02