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Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acute Intermittent Hypoxia
Sham Acute Intermittent Hypoxia
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Spinal cord lesion at level of C3 to T1
  2. Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
  3. Individuals must be at least 6 months status post injury
  4. Individuals must be between the ages of 18-70 years inclusive, male or female
  5. Spinal cord injury must be secondary to a non-progressive etiology
  6. Individuals must be medically stable.
  7. Able to comply with protocol/study requirements
  8. Not currently (>2 weeks) taking any medications for spasticity management.

Exclusion Criteria:

  1. Recent change in the use of narcotic, anti-inflammatory or pain medication
  2. 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
  3. History of sleep apnea
  4. Active participation in another movement research study or therapy program
  5. Anti-spasticity drug injection less than 3 months, prior to beginning treatment
  6. Musculoskeletal pain that interferes with participation in study
  7. Women who are currently, may be or planning on becoming pregnant

Sites / Locations

  • Rehabilitation Institute of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Single session of Acute Intermittent Hypoxia (AIH)

Single session of Sham Acute Intermittent Hypoxia (Sham AIH)

Two successive sessions of AIH

Two successive sessions of Sham AIH

Arm Description

Outcomes

Primary Outcome Measures

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.
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).
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.
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

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
February 17, 2020
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT03774043
Brief Title
Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
Official Title
Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single session of Acute Intermittent Hypoxia (AIH)
Arm Type
Experimental
Arm Title
Single session of Sham Acute Intermittent Hypoxia (Sham AIH)
Arm Type
Placebo Comparator
Arm Title
Two successive sessions of AIH
Arm Type
Experimental
Arm Title
Two successive sessions of Sham AIH
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Acute Intermittent Hypoxia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Acute Intermittent Hypoxia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in grip strength
Description
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.
Time Frame
Baseline, immediately following intervention, and every 30 minutes for 5 hours
Title
Pinch Strength
Description
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).
Time Frame
Baseline, immediately following intervention, and every 30 minutes for 5 hours
Title
9 Hole Peg Test
Description
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.
Time Frame
Baseline, immediately following intervention, and every 30 minutes for 5 hours
Title
Box and Blocks test
Description
A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds
Time Frame
Baseline, immediately following intervention, and every 30 minutes for 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milap Sandhu, PT, PhD
Phone
3122386529
Email
m-sandhu@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Anastasopoulos
Email
sanastasop@ric.org
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milap S Sandhu, PT, PhD
Phone
312-238-6529
Email
m-sandhu@northwestern.edu

12. IPD Sharing Statement

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Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

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