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NCT Number: NCT06276634

Intermittent Hypoxia in Persons With Multiple Sclerosis

This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Hypoxia Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis-Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alexander Barry, MS, CCRC

CONTACT

[email protected]

3122381435

Milap Sandhu, PT, PhD

PRINCIPAL_INVESTIGATOR

Molly Bright, D.Phil.

SUB_INVESTIGATOR

About this study

Recent research has shown that AIH, characterized by brief episodes of reduced oxygen levels in the inspired air, has the potential to induce neural adaptations. These adaptations are suspected to influence several aspects of neuroplasticity, including the modulation of neurotransmitters and neurotrophic factors. Persons with MS typically exhibit greater cortical activation to achieve a given motor task compared to healthy controls, suggesting compensatory activations in motor cortices and the recruitment of additional non-motor regions for successful motor control. Therefore, interventions that promote adaptive neuroplasticity in motor control systems may induce a reduction in fMRI activation during motor tasks as well as an increase in functional connectivity between somatomotor cortices. This study will explore potential mechanisms of this intervention in MS using motor task performance and advanced neuroimaging techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)
  • Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
  • Motor Functional System Scale (FSS) between 2-4
  • Relapse free for at least 1 year
  • Age ≥ 18 years and ≤ 75 years
  • Safe to be scanned based on MRI questionnaire
  • Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Exclusion criteria

  • Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
  • Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
  • History of epilepsy
  • Chronic obstructive pulmonary disease
  • Uncontrolled Sleep apnea
  • Pregnancy

Treatment and study plan

Acute Intermittent Hypoxia

Other

During each AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles: one with lower oxygen concentration (9-10% Oxygen) than that at sea level (~21% Oxygen) lasting between 30 and 60 seconds, followed by a similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.

Other names: AIH

Sham-Acute Intermittent Hypoxia

Other

During each Sham-AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the Sham-AIH intervention. The Sham-AIH intervention involves alternating breathing cycles: both with oxygen concentrations of ~21% Oxygen lasting between 30 and 60 seconds, followed by another similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.

Primary outcomes

  1. Ankle Plantarflexion Strength

    Time frame: Before and following each 5-day intervention block

    Participants will be seated in an adjustable chair with tested foot secured to a foot plate with the ankle in line with a rotational load cell. Participants will be asked to produce maximal ankle plantarflexion contractions, Electromyographic signals of the gastrocnemius, tibialis anterior, and soleus will be recorded simultaneously

Secondary outcomes

  1. Task fMRI

    Time frame: Before and following each 5-day intervention block

    This outcome observes neural activations during voluntary muscle activations

Other outcomes

  1. Timed 25 Feet Walk test

    Time frame: Before and following each 5-day intervention block

    A part of the MS functional composite. Participants will be directed to walk across a 25-foot course as quickly and safely as possible.

  2. Six-Minute Walk test

    Time frame: Before and following each 5-day intervention block

    The Six-minute walk test is an assessment to measure the distance able to be traversed by a participant in 6-minutes

  3. Stride length

    Time frame: Before and following each 5-day intervention block

    This assessment involves walking at normal walking pace over flat ground. The GAITRite®, a pressure sensitive walkway, will be used to measure and analyze spatiotemporal gait parameters, particularly stride length in meters

  4. 12-Item Multiple Sclerosis walk scale (MSWS-12)

    Time frame: Before and following each 5-day intervention block

    This is a self-reported measure of the impact of MS on an individual's walking ability Minimum score: 12 Maximum score: 60 A lower score indicates better walking ability, less affected by the multiple sclerosis

  5. Resting-State fMRI

    Time frame: Before and following each 5-day intervention block

    Participants will undergo an 2D T2* weighted multi-band multi-echo gradient echo-planar imaging sequence at rest

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Barry, MS, CCRC

CONTACT

[email protected]

3122381435

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Northwestern University

Registry information

Official study title

Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Feb 26, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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