Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

Shirley Ryan AbilityLab

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Other: Acute Intermittent Hypoxia; Other: Sham Acute Intermittent Hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT03774043

STU00202027

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Single session of Acute Intermittent Hypoxia (AIH)

Experimental group

Treatment:

Other: Acute Intermittent Hypoxia

Single session of Sham Acute Intermittent Hypoxia (Sham AIH)

Placebo Comparator group

Treatment:

Other: Sham Acute Intermittent Hypoxia

Two successive sessions of AIH

Experimental group

Treatment:

Other: Acute Intermittent Hypoxia

Two successive sessions of Sham AIH

Placebo Comparator group

Treatment:

Other: Sham Acute Intermittent Hypoxia