Clinical trial NCT03433599: Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Official title: Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Acute Intermittent Hypoxia
Transcranial Magnetic Stimulation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2018-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Upper limb functional measurement
timeFrame: 45 minutes to 1 hour
measure: Lower limb functional measurement
timeFrame: 5-10 minutes
measure: MEP/CMEP recruitment curves using TMS
timeFrame: 30 minutes to 1 hour
measure: EMG and force voluntary output
timeFrame: 30 minutes to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Monica A Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References: