NCT03433599

Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI).

Detailed description

The experiments in this study will test the following: Hypothesis 1.1(Experiment 1) that rAIH will enhance corticospinal excitability and upper and lower limb function in humans with incomplete SCI. Hypothesis 1.2 (Experiment 2) that enhancing the aftereffects of rAIH with exercise training will further enhance upper and lower limb motor function in humans with incomplete SCI. Measurements of corticospinal, cortical, and motoneuron excitability will be tested to further understand the mechanisms of this induced-plasticity. Persons with chronic (\>6 months) spinal cord injury between the levels of C2 and T2. SCI subjects must possess either the ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. Additionally, subject must possess the ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Controls must be right handed due to potential differences in the organization of the brain in right handed and left handed individuals.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Repeated exposure to acute Intermittent Hypoxia (rAIH)	Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).
OTHER	Normal Room Air	Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).
OTHER	Upper-limb Training by Research Staff	Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, gross grasping, fine grasping, and hand cycle using an arm ergometer. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.
OTHER	Lower-limb Training by Research Staff	Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general leg/foot movement, over-ground walking, treadmill walking, stair climbing training, leg cycling, standing frame, and NuStep. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Timeline

• Start date: 2020-04-09
• Primary completion: 2024-12-28
• Completion: 2025-12-28
• First posted: 2018-02-14
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States