Intermittent Hypoxia in Persons With Multiple Sclerosis

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Multiple Sclerosis; Multiple Sclerosis-Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive

Treatments: Other: Acute Intermittent Hypoxia; Other: Sham-Acute Intermittent Hypoxia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06276634

STU00219535

R21HD108587 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

AIH First

Experimental group

Description:

Participants in the AIH First arm will undergo 5 days of Acute Intermittent Hypoxia Interventions. Following the 5 Days of AIH, after a 2-week washout period, this group will then undergo 5 days of Sham AIH Interventions. The procedures are identical to AIH but with 21% oxygen for both breath cycles

Treatment:

Other: Sham-Acute Intermittent Hypoxia

Other: Acute Intermittent Hypoxia

Sham First

Experimental group

Description:

Participants in the Sham First arm will undergo 5 days of Sham-Acute Intermittent Hypoxia Interventions. Following the 5 Days of Sham-AIH, after a 2-week washout period, this group will then undergo 5 days of AIH Interventions. The procedures are identical to Sham-AIH but with 9-10% oxygen for the first breath cycle

Treatment:

Other: Sham-Acute Intermittent Hypoxia

Other: Acute Intermittent Hypoxia