Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI

September 26, 2023 updated by: Molly Bright, Northwestern University

Neurovascular Mechanisms of Intermittent Hypoxia Induced Neural Plasticity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All participants must meet the following inclusion criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Intermittent Hypoxia
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD fMRI activation in motor cortex during isometric hand grip tasks
Time Frame: Immediately before and ~ 1-hour after AIH on the same day
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
Time Frame: Immediately before and ~ 1-hour after AIH on the same day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Molly G Bright, DPhil, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0051925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

MR imaging data and the associated physiologic data collected during MRI scanning will be shared in an anonymized format. These data will be made available to public through the Open Science Framework (osf.io) or similar public repository.

IPD Sharing Time Frame

At time of publication (or within one year of project completion, whichever occurs first).

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Acute Intermittent Hypoxia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe