NCT02632422

AIH-induced Walking Recovery After Subacute SCI

Intermittent Hypoxia-Induced Recovery of Overground Walking in Persons With Subacute SCI

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
OTHER	Daily acute intermittent hypoxia (dAIH)	Each participant will be exposed to 10 sessions of daily acute intermittent hypoxia (dAIH) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily acute intermittent hypoxia (dAIH).
OTHER	dSHAM	Each participant will be exposed to 10 sessions of daily room air (dSHAM) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily room air (dSHAM).
OTHER	Walking	Participants will participate in 10 days of walking practice sessions. Walking practice sessions will immediately follow (within 60 minutes) the breathing intervention during training visits and will last for 60 minutes. Walking practice will incorporate 5 walking-related tasks: 1. walking balance (e.g., walking with turns) 2. skilled walking tasks (e.g., negotiating obstacles) 3. walking with secondary task (e.g., walking and talking) 4. endurance 5. speed

Timeline

• Start date: 2015-10-01
• Primary completion: 2023-07-07
• Completion: 2027-12-30
• First posted: 2015-12-16
• Last updated: 2025-10-31

Locations

2 sites across 1 country: United States