NCT03922802

SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training

Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury.

Detailed description

OBJECTIVES: * To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training modulates spinal locomotor networks in individuals with spinal cord injury * To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves locomotor function in individuals with spinal cord injury * To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves symmetry of gait in individuals with spinal cord injury * To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves standing posture and balance in individuals with spinal cord injury * To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with a combination of AIH, transcutaneous spinal cord stimulation and ambulation training in individuals with spinal cord injury

Conditions

• Spinal Cord Injuries
• Spinal Cord Diseases

Interventions

Type	Name	Description
DEVICE	Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Subjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.
OTHER	Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
OTHER	Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training	Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2019-04-22
• Last updated: 2026-01-13
• Results posted: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study