Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Launched by SHIRLEY RYAN ABILITYLAB · Feb 8, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people recover from spinal cord injuries (SCI) by using a method called repetitive acute intermittent hypoxia (rAIH). This technique involves exposing the body to short periods of low oxygen, which may help improve the function of the upper and lower limbs in individuals who have had a spinal cord injury for at least six months. The researchers hope to find out if this method can help people regain some movement or strength after their injury.

To participate in the trial, individuals must be between 18 and 85 years old and have a spinal cord injury at or above the L2 level. They should be able to show some hand movement or muscle contractions in their legs. There is also a control group for right-handed individuals without spinal cord injuries. Participants can expect to be part of a supportive environment where they will undergo training and assessments to track their progress. It’s important to note that certain medical conditions, like heart problems or ongoing mental health issues, may prevent someone from joining the study.

Gender

ALL

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