21 Participants Needed

Intermittent Hypoxia for Multiple Sclerosis

AB
Overseen ByAlexander Barry, MS, CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using dalfampridine, you must have been on the same daily dose for at least 2 months before joining the study.

How is the treatment Acute Intermittent Hypoxia (AIH) unique for Multiple Sclerosis (MS)?

Acute Intermittent Hypoxia (AIH) is a novel, non-invasive treatment that involves brief periods of breathing low-oxygen air, which can enhance the body's ability to repair nerve damage and reduce inflammation in Multiple Sclerosis (MS). Unlike other treatments, AIH promotes remyelination (repair of nerve coverings) and alters the disease course by improving functional recovery and reducing inflammation.12345

What data supports the effectiveness of the treatment Intermittent Hypoxia for Multiple Sclerosis?

Research shows that acute intermittent hypoxia (AIH) can improve nerve repair and reduce inflammation in a mouse model of Multiple Sclerosis (MS), suggesting it may help repair the nervous system and alter the disease course in MS.23567

Who Is on the Research Team?

MS

Milap Sandhu, Pt, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for people with multiple sclerosis (MS) who are interested in a novel intervention that involves breathing low levels of oxygen intermittently, similar to the air on a tall mountain. The study will explore how this affects brain activation and ankle strength.

Inclusion Criteria

I have been free from cancer relapse for at least 1 year.
My motor function is moderately impaired.
My disability level is moderate to severe but I can still walk.
See 3 more

Exclusion Criteria

Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
History of epilepsy
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5 days of Acute Intermittent Hypoxia (AIH) or Sham-AIH interventions, followed by a 2-week washout period, and then another 5 days of the alternate intervention

4 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neural activations and motor performance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acute Intermittent Hypoxia
  • Sham-Acute Intermittent Hypoxia
Trial Overview The study is testing Acute Intermittent Hypoxia (AIH), where participants breathe short bursts of low-oxygen air. It compares AIH's effects on brain function and muscle strength against a sham procedure (a fake treatment that mimics AIH without using actual low oxygen).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Sham FirstExperimental Treatment2 Interventions
Group II: AIH FirstExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials
212
Recruited
17,900+

Northwestern University

Collaborator

Trials
1,674
Recruited
989,000+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

The study found that individuals with the APOE 4 genotype showed lower diaphragm motor-evoked potential (MEP) enhancements in response to acute intermittent hypercapnic-hypoxia (AIHH), indicating that genetic factors can influence the effectiveness of this rehabilitation strategy.
Additionally, the research revealed that males had a greater enhancement in diaphragm MEP compared to females, and that age negatively affected respiratory motor plasticity, highlighting the importance of biological factors in individual responses to AIHH.
APOE4, Age & Sex Regulate Respiratory Plasticity Elicited By Acute Intermittent Hypercapnic-Hypoxia.Nair, J., Welch, JF., Marciante, AB., et al.[2023]
Acute intermittent hypoxia (AIH) significantly improved functional recovery and reduced inflammation in a mouse model of Multiple Sclerosis (EAE), indicating its potential as a non-invasive therapy for CNS repair.
AIH enhanced myelination and recruited oligodendrocyte precursor cells to demyelinated areas, suggesting it could alter the disease course and promote neuroregeneration in MS.
Acute intermittent hypoxia alters disease course and promotes CNS repair including resolution of inflammation and remyelination in the experimental autoimmune encephalomyelitis model of MS.Tokarska, N., Naniong, JMA., Johnston, JM., et al.[2023]
Intermittent hypoxia (IH) in a rat model led to increased inflammation in the liver and a significant decrease in the expression of cytochrome P450 enzymes, which are crucial for drug metabolism.
The study highlights the potential risk for patients with obstructive sleep apnea (OSA) who are on medications metabolized by the liver, as IH may impair liver function and drug processing.
Hepatic Cyp1a2 Expression Reduction during Inflammation Elicited in a Rat Model of Intermittent Hypoxia.Shi, LX., Wang, X., Wu, Q., et al.[2021]

Citations

APOE4, Age & Sex Regulate Respiratory Plasticity Elicited By Acute Intermittent Hypercapnic-Hypoxia. [2023]
Acute intermittent hypoxia alters disease course and promotes CNS repair including resolution of inflammation and remyelination in the experimental autoimmune encephalomyelitis model of MS. [2023]
Hepatic Cyp1a2 Expression Reduction during Inflammation Elicited in a Rat Model of Intermittent Hypoxia. [2021]
Intermittent Hypobaric Hypoxic Preconditioning Provides Neuroprotection by Increasing Antioxidant Activity, Erythropoietin Expression and Preventing Apoptosis and Astrogliosis in the Brain of Adult Rats Exposed to Acute Severe Hypoxia. [2021]
Effects of acute intermittent hypoxia on corticospinal excitability within the primary motor cortex. [2022]
The effect of two different intermittent hypoxia protocols on ventilatory responses to hypoxia and carbon dioxide at rest. [2016]
APOE4, Age, and Sex Regulate Respiratory Plasticity Elicited by Acute Intermittent Hypercapnic-Hypoxia. [2023]
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