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Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Not Applicable
Recruiting
Conditions
Spinal Cord Injuries
Interventions
Other: Repeated exposure to acute Intermittent Hypoxia (rAIH)
Other: Normal Room Air
Other: Upper-limb Training by Research Staff
Other: Lower-limb Training by Research Staff
Registration Number
NCT03433599
Lead Sponsor
Shirley Ryan AbilityLab
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
rAIH + training by research staffRepeated exposure to acute Intermittent Hypoxia (rAIH)Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
sham rAIH + trainingNormal Room AirParticipants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
rAIH + training by research staffUpper-limb Training by Research StaffParticipants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
rAIH + training by research staffLower-limb Training by Research StaffParticipants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
sham rAIH + trainingUpper-limb Training by Research StaffParticipants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
sham rAIH + trainingLower-limb Training by Research StaffParticipants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
Primary Outcome Measures
NameTimeMethod
Upper limb functional measurement45 minutes to 1 hour

The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.

Lower limb functional measurement5-10 minutes

10-meter walk test will be used to assess walking speed

MEP/CMEP recruitment curves using TMS30 minutes to 1 hour

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).

EMG and force voluntary output30 minutes to 1 hour

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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Shirley Ryan AbilityLab

🇺🇸

Chicago, Illinois, United States

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