Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

NCT02274116 | Active Not Recruiting

• 1 other identifier: 2017P001940c
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time. The investigators hypothesize:

• Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI)
• AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI
• AIH exposure will increase walking performance in persons with incomplete cervical SCI

Conditions

Spinal Cord Injuries

Keywords

acute intermittent hypoxia; walking; spasticity; incomplete spinal cord injury; breathing; strength

Outcome Measures

Primary Outcomes (1)

• Change in overground walking endurance

  walking endurance (6 minute walk test - how far one can walk in 6 minutes)

  Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

Secondary Outcomes (1)

• Change in overground walking speed

  Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

Study Arms (2)

Intermittent Hypoxia (AIH)

ACTIVE COMPARATOR

Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen. Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes

Other: AIH - Intermittent Hypoxia - hypoxia air mixture

Intermittent Room Air (SHAM)

SHAM COMPARATOR

Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air. Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes

Other: SHAM - Intermittent Room Air - room air mixture

Interventions

SHAM - Intermittent Room Air - room air mixture OTHER

Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 5 times per week for 2 weeks.

Intermittent Room Air (SHAM)

AIH - Intermittent Hypoxia - hypoxia air mixture OTHER

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 5 times per week for 2 weeks.

Intermittent Hypoxia (AIH)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old (the latter to reduce likelihood of heart disease);
• medically stable with clearance from physician to participate;
• motor---incomplete SCI at C2---L5 with non---progressive etiology;
• \>6 months since SCI to ensure minimal confounds of spontaneous neurological recovery;
• those classified as ambulatory must have the ability to advance one step overground without human assistance.

You may not qualify if:

• concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs;
• less than 24 on the Mini-mental Exam;
• recurrent autonomic dysreflexia
• cardiopulmonary complications
• concurrent physical therapy
• pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Foundation Wings For Life: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (4)

• Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.

  PMID: 24285617 BACKGROUND

• Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.

  PMID: 21821826 BACKGROUND

• Lovett-Barr MR, Satriotomo I, Muir GD, Wilkerson JE, Hoffman MS, Vinit S, Mitchell GS. Repetitive intermittent hypoxia induces respiratory and somatic motor recovery after chronic cervical spinal injury. J Neurosci. 2012 Mar 14;32(11):3591-600. doi: 10.1523/JNEUROSCI.2908-11.2012.

  PMID: 22423083 BACKGROUND

• Dale-Nagle EA, Hoffman MS, MacFarlane PM, Satriotomo I, Lovett-Barr MR, Vinit S, Mitchell GS. Spinal plasticity following intermittent hypoxia: implications for spinal injury. Ann N Y Acad Sci. 2010 Jun;1198:252-9. doi: 10.1111/j.1749-6632.2010.05499.x.

  PMID: 20536940 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Randy D Trumbower, PT, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)