Recruiting
Phase 1
Phase 2

Acute Intermittent Hypoxia

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT03774043

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Acute Intermittent Hypoxia

Sham Acute Intermittent Hypoxia

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT03774043

Start date

May, 2016

Status verified date

Feb, 2020

Completion date

Jul, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single session of Acute Intermittent Hypoxia (AIH)

placebo comparator: Single session of Sham Acute Intermittent Hypoxia (Sham AIH)

experimental: Two successive sessions of AIH

placebo comparator: Two successive sessions of Sham AIH

Interventions

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.

Primary outcome measure

  • Change in grip strength [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
  • Pinch Strength [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
  • 9 Hole Peg Test [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
  • Box and Blocks test [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]

Central Contacts and Locations

Central contacts

Sofia Anastasopoulos

sanastasop@ric.org

Locations

Rehabilitation Institute of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Feb 19, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2020-02-19.