An interventional study of Repeated exposure to acute Intermittent Hypoxia (rAIH) and Normal Room Air in Spinal Cord Injuries, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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).
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.
Inclusion criteria for SCI:
Inclusion criteria for controls:
Exclusion criteria for SCI and for controls:
AIH exclusion criteria (in addition to the above listed exclusion criteria)
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
Other: Repeated exposure to acute Intermittent Hypoxia (rAIH) · Other: Upper-limb Training by Research Staff · Other: Lower-limb Training by Research Staff
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
Other: Normal Room Air · Other: Upper-limb Training by Research Staff · Other: Lower-limb Training by Research Staff
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).
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).
Also known as: Sham repeated exposure to acute Intermittent Hypoxia (rAIH)
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.
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.
Upper limb functional measurement
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.
Time frame: 45 minutes to 1 hour
Lower limb functional measurement
10-meter walk test will be used to assess walking speed
Time frame: 5-10 minutes
MEP/CMEP recruitment curves using TMS
Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).
Time frame: 30 minutes to 1 hour
EMG and force voluntary output
EMG surface electrodes will be placed over target muscles (deltoid, biceps brachii, first dorsal interosseous, abductor pollicis brevis, quadriceps femoris, tibialis anterior and/or soleus) to measure maximum voluntary contraction (MVC)
Time frame: 30 minutes to 1 hour
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