Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI

NCT05183113 | Completed

• 1 other identifier: SP0051925
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Acute Intermittent Hypoxia; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• BOLD fMRI activation in motor cortex during isometric hand grip tasks

  Assess AIH-induced changes in %BOLD activation within the left and right motor cortices during unilateral isometric hand grasping tasks targeting submaximal force levels with real-time feedback.

  Immediately before and ~ 1-hour after AIH on the same day

• BOLD fMRI vascular reactivity to a breath-hold task

  Measurements of breath-hold induced vasodilation (vascular reactivity, in units of %BOLD/mmHg end-tidal CO2) acquired via functional MRI in the brain and spinal cord.

  Immediately before and ~ 1-hour after AIH on the same day

Study Arms (1)

Acute Intermittent Hypoxia

EXPERIMENTAL

Both healthy participants and those with spinal cord injury will receive the acute intermittent hypoxia (AIH) intervention. All participants are imaged pre- and post-AIH intervention, and thus serve as a self-comparison to observe the hypothesized improvement in bilateral hand strength.

Other: Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia OTHER

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.

Acute Intermittent Hypoxia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-60 years
• Safe to be scanned using MRI
• Able to communicate in English
• Ability to sign informed consent
• In addition, the participants recruited with SCI must meet the following criteria:
• History of a traumatic spinal cord injury, inclusive of levels C2-T1
• At least 6 months since onset of spinal cord injury
• Cause of the spinal cord injury was non-progressive
• Ability to complete and comply with information within the informed consent
• Ability to close and open at least one hand without assistance

You may not qualify if:

• MRI contraindications as indicated on MRI safety screening form
• Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
• Women who are currently pregnant, nursing, or planning on becoming pregnant
• Individuals with severe claustrophobia
• Subjects unwilling or unable to give written informed consent in English
• Prisoners
• Frequent smokers (greater than 5 cigarettes per day)
• Blood pressure greater than 160/110 or less than 85/55.
• Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study.
• Diagnosis of any of the following comorbid conditions: congestive heart failure, cardiac arrhythmias, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction or known carotid/intracerebral artery stenosis, presence of active deep venous thrombosis, or cancer.
• Individuals who utilize mechanical ventilation or have a tracheostomy
• Individuals who utilize an intrathecal baclofen pump
• Orthopedic injury affecting upper extremities
• Currently participating in any other hypoxia related study.

Sponsors & Collaborators

• Northwestern University: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Golder FJ, Mitchell GS. Spinal synaptic enhancement with acute intermittent hypoxia improves respiratory function after chronic cervical spinal cord injury. J Neurosci. 2005 Mar 16;25(11):2925-32. doi: 10.1523/JNEUROSCI.0148-05.2005.

  PMID: 15772352 BACKGROUND

• Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.

  PMID: 28972191 BACKGROUND

• Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.

  PMID: 21821826 BACKGROUND

• Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.

  PMID: 24285617 BACKGROUND

• Li Y, Lucas-Osma AM, Black S, Bandet MV, Stephens MJ, Vavrek R, Sanelli L, Fenrich KK, Di Narzo AF, Dracheva S, Winship IR, Fouad K, Bennett DJ. Pericytes impair capillary blood flow and motor function after chronic spinal cord injury. Nat Med. 2017 Jun;23(6):733-741. doi: 10.1038/nm.4331. Epub 2017 May 1.

  PMID: 28459438 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Molly G Bright, DPhil

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; Physical Therapy and Human Movement Sciences; Feinberg School of Medicine

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 10, 2022
• Study Start: May 20, 2019
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: At time of publication (or within one year of project completion, whichever occurs first).
• Access Criteria: Data will be anonymized and made publicly available, and at that time no approval is needed and therefore there are no access criteria.

Locations

US (1)