AIH-induced Walking Recovery After Subacute SCI

Mass General Brigham

Status: Active, not recruiting

Conditions: Spinal Cord Injury

Treatments: Other: Daily acute intermittent hypoxia (dAIH); Other: dSHAM; Other: Walking

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02632422

2017P001941

Details and patient eligibility

About

The purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.

Full description

The goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) improves recovery of walking and strength after spinal cord injury. This idea stems from animal studies on respiration, in which investigators showed that mild AIH improves breathing in rats with spinal injuries. These studies showed that AIH induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. The ultimate goal of this research is to assess the potential of mild AIH as a therapeutic approach not only in persons with chronic spinal cord injury but also in persons with subacute injury. By applying AIH during early stages of recovery, the investigators hope to expand the potential benefits of AIH to a broader range of persons with spinal injury, thereby improving functional independence and quality of life for servicemen and civilians.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 70 years old
• medically stable with medical clearance from physician to participate
• spinal cord injury (SCI) at or below C3 (phrenic sparing) and above L5 with at least motor function preserved below the neurologic level
• non-progressive etiology of spinal injury
• American Spinal Injury Association Impairment Scale (AIS) grade A-D
• 2-12 months post-injury (subacute)

Exclusion criteria

• severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection (e.g. bladder), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis (history of fractures), active heterotopic ossification in the lower extremities, or history of peripheral nerve injury in the legs
• score less than 24 on Mini-Mental Exam
• severe autonomic dysreflexia
• history of cardiovascular/pulmonary complications
• pregnancy
• severe obstructive sleep apnea (OSA), characterized by uncontrolled hypoxia and sleep fractionation

Specific inclusion/exclusion criteria for recruiting non-ambulatory subjects:

Participation in this group requires all of the above inclusion/exclusion criteria, as well as being unable to complete any of the below measures:

• timed up-and-go (TUG) test
• 10-meter walk test (10MWT)
• 6-minute walk test (6MWT)

Specific inclusion/exclusion criteria for recruiting ambulatory subjects:

Participation in this group requires all of the above criteria, as well as successful completion of at least one below measure:

• timed up-and-go (TUG) test
• 10-meter walk test (10MWT)
• 6-minute walk test (6MWT)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

125 participants in 5 patient groups

Non-ambulatory - dAIH

Experimental group

Description:

Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) 10 treatment visits at a frequency of 5 days each week for 2 weeks.

Treatment:

Other: Daily acute intermittent hypoxia (dAIH)

Non-ambulatory - dSHAM

Sham Comparator group

Description:

Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) 10 treatment visits at a frequency of 5 days each week for 2 weeks.

Treatment:

Other: dSHAM

Ambulatory - dAIH+Walk

Experimental group

Description:

Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.

Treatment:

Other: Walking

Other: Daily acute intermittent hypoxia (dAIH)

Ambulatory - dSHAM+Walk

Sham Comparator group

Description:

Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.

Treatment:

Other: Walking

Other: dSHAM

Ambulatory-Walk

Other group

Description:

Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.

Treatment:

Other: Walking