Clinical trial NCT06276634: Intermittent Hypoxia in Persons With Multiple Sclerosis
Official title: Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis-Relapsing-Remitting
Multiple Sclerosis, Secondary Progressive
Keywords: multiple sclerosis
AIH
Hypoxia
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Northwestern University
First posted: 2024-02-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ankle Plantarflexion Strength
timeFrame: Before and following each 5-day intervention block
Secondary outcomes:
measure: Task fMRI
timeFrame: Before and following each 5-day intervention block
Other outcomes:
measure: Timed 25 Feet Walk test
timeFrame: Before and following each 5-day intervention block
measure: Six-Minute Walk test
timeFrame: Before and following each 5-day intervention block
measure: Stride length
timeFrame: Before and following each 5-day intervention block
measure: 12-Item Multiple Sclerosis walk scale (MSWS-12)
timeFrame: Before and following each 5-day intervention block
measure: Resting-State fMRI
timeFrame: Before and following each 5-day intervention block
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Milap Sandhu, Pt, PhD
role: PRINCIPAL_INVESTIGATOR
References: