Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Lower-limb Training by Research Staff; Other: Repeated exposure to acute Intermittent Hypoxia (rAIH); Other: Normal Room Air; Other: Upper-limb Training by Research Staff

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03433599

STU00212000

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for SCI:

1. Males and females between 18-85 years
2. Chronic SCI (≥ 6 months post injury)
3. SCI at or above L2
4. ASIA A, B, C, or D, complete or incomplete
5. Possess the following: The ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles.

Inclusion criteria for controls:

1. Males and females between 18-85 years
2. Right-handed (Only right-handed individuals will be accepted into this group because of the potential differences in the organization of the brain in right handed and left handed individuals)

Exclusion criteria for SCI and for controls:

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
2. Any debilitating disease prior to the SCI that caused exercise intolerance
3. Premorbid, ongoing major depression or psychosis, altered cognitive status
4. History of head injury or stroke
5. Metal plate in skull
6. History of seizures
7. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant
8. Pregnant females
9. Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk.

AIH exclusion criteria (in addition to the above listed exclusion criteria)

1. Resting heart rate ≥120 BPM
2. Resting systolic blood pressure >180 mm Hg
3. Resting diastolic Blood Pressure >100 mmHg
4. Self-reported history of unstable angina or myocardial infarction within the previous month
5. Resting SpO2 ≥ 95%
6. Cardiopulmonary complications such as COPD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

rAIH + training by research staff

Active Comparator group

Description:

Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.

Treatment:

Other: Upper-limb Training by Research Staff

Other: Repeated exposure to acute Intermittent Hypoxia (rAIH)

Other: Lower-limb Training by Research Staff

sham rAIH + training

Sham Comparator group

Description:

Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.

Treatment:

Other: Upper-limb Training by Research Staff

Other: Normal Room Air

Other: Lower-limb Training by Research Staff