Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

Spinal Cord Injuries Clinical Trial

Official title:

Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774043
• Other study ID #: STU00202027
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Shirley Ryan AbilityLab
• Contact: Milap Sandhu, PT, PhD
• Phone: 3122386529
• Email: m-sandhu[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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