Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

NCT03433599 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-30

No results posted yet for this study

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).

Conditions

  • Spinal Cord Injuries

Interventions

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.

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED
  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Monica A Perez, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-09
Primary Completion
2024-12-28
Completion
2025-12-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433599 on ClinicalTrials.gov