NCT05183113

Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI

Neurovascular Mechanisms of Intermittent Hypoxia Induced Neural Plasticity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord injury and uninjured controls will enable characterization of changes in neurovascular physiology caused by this promising new therapy.

Detailed description

Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant transient improvements in respiratory function, plantar flexion, locomotor function, and hand dexterity and strength. Although these studies observe some degree of success eliciting plasticity, we lack a framework for systematic optimization of the AIH protocol for individual patients. Better understanding of what physiological mechanisms drive AIH-induced neural plasticity in humans will directly inform the development of AIH as an effective treatment option in chronic SCI. This study applies magnetic resonance imaging (MRI) to test how AIH influences vascular and neural properties of the brain and spinal cord. Individuals with SCI and uninjured participants will be recruited to undergo two MRI scan sessions on one day. In between these scan sessions, participants will undergo a single 30-minute session of AIH. In each scan session, functional MRI will assess AIH-induced changes in neural activation patterns during motor tasks (unilateral isometric hand grasping tasks) and vascular reactivity to breath hold tasks (transient hypocapnia to induce vasodilation). Additional structural scans will be acquired to aid in image analysis.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Acute Intermittent Hypoxia	Participants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol.

Timeline

• Start date: 2019-05-20
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2022-01-10
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States