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.

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 Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Acute Intermittent Hypoxia; Other: Sham Acute Intermittent Hypoxia

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Milap Sandhu, PT, PhD; Phone Number: 3122386529; Email: m-sandhu@northwestern.edu
• Study Contact Backup: Name: Sofia Anastasopoulos; Email: sanastasop@ric.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Rehabilitation Institute of Chicago
      • Contact: Milap S Sandhu, PT, PhD; Phone Number: 312-238-6529; Email: m-sandhu@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single session of Acute Intermittent Hypoxia (AIH)	Other: Acute Intermittent Hypoxia; 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.
Placebo Comparator: Single session of Sham Acute Intermittent Hypoxia (Sham AIH)	Other: Sham Acute Intermittent Hypoxia; 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.
Experimental: Two successive sessions of AIH	Other: Acute Intermittent Hypoxia; 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.
Placebo Comparator: Two successive sessions of Sham AIH	Other: Sham Acute Intermittent Hypoxia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Signs and Symptoms, Respiratory; Spinal Cord Diseases; Spinal Cord Injuries; Hypoxia
• Other Study ID Numbers: STU00202027