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Clinical Trials/NCT06276634
NCT06276634
Recruiting
Not Applicable

Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis

Shirley Ryan AbilityLab2 sites in 1 country21 target enrollmentApril 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Shirley Ryan AbilityLab
Enrollment
21
Locations
2
Primary Endpoint
Ankle Plantarflexion Strength
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2024
End Date
January 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Milap Sandhu

Principal Investigator

Shirley Ryan AbilityLab

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

Outcomes

Primary Outcomes

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

  • Task fMRI(Before and following each 5-day intervention block)

Study Sites (2)

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