Intermittent Hypoxia in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276634
• Other study ID #: STU00219535
• Secondary ID: R21HD108587
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: January 2027

Study information

• Verified date: April 2024
• Source: Shirley Ryan AbilityLab
• Contact: Alexander Barry, MS, CCRC
• Phone: 3122381435
• Email: abarry[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Secondary Progressive
• Multiple Sclerosis-Relapsing-Remitting
• Sclerosis

Intervention

Other:
• Acute Intermittent Hypoxia
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.
• Sham-Acute Intermittent Hypoxia
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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timed 25 Feet Walk test	A part of the MS functional composite. Participants will be directed to walk across a 25-foot course as quickly and safely as possible.	Before and following each 5-day intervention block
Other	Six-Minute Walk test	The Six-minute walk test is an assessment to measure the distance able to be traversed by a participant in 6-minutes	Before and following each 5-day intervention block
Other	Stride length	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	Before and following each 5-day intervention block
Other	12-Item Multiple Sclerosis walk scale (MSWS-12)	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	Before and following each 5-day intervention block
Other	Resting-State fMRI	Participants will undergo an 2D T2* weighted multi-band multi-echo gradient echo-planar imaging sequence at rest	Before and following each 5-day intervention block
Primary	Ankle Plantarflexion Strength	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	Before and following each 5-day intervention block
Secondary	Task fMRI	This outcome observes neural activations during voluntary muscle activations	Before and following each 5-day intervention block