Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect
      motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle
      weakness are common in the terminal stages of MS and contribute to mortality in these
      patients. Respiratory muscle weakness may also impair the performance of coughing and
      aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic
      stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through
      nerve activation. Over the last few years, the study investigators have demonstrated efficacy
      of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects
      [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will
      investigate the efficacy of using FMS technique for respiratory muscle conditioning in
      patients with MS. Furthermore, the investigators will also compare expiration related
      outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.

      Hypotheses

        1. FMS conditioning of the expiratory muscles can generate significant expiratory flows and
           pressures in patients with MS.

        2. FMS conditioning of expiratory muscles is more effective compared to resistive
           expiratory muscle training (REMT) in patients with MS.
    

Detailed description: 
      Optimal respiratory function depends on intact neural circuitry which orchestrates the
      interplay between respiratory muscles and intrinsic pulmonary function to maintain adequate
      ventilation. In the absence of respiratory muscle activation, pressure gradients cannot be
      developed and air exchange at the alveolar surface cannot occur. Thus, any impairment in
      respiratory muscle performance can lead to pulmonary dysfunction, respiratory distress and
      even death. Multiple sclerosis (MS) is a primary disorder of the central nervous system that
      often affects motor pathways, causing diminished muscle strength and endurance throughout the
      body including the ventilatory muscles. Respiratory complications are recognized as the major
      cause of morbidity and mortality in individuals with advanced MS. The investigators' research
      team has over 15 years of experience using Functional Magnetic Stimulation (FMS) for
      stimulating nerves and muscles below the level of injury in patients with chronic SCI; and
      has also demonstrated significant benefit for improving respiratory muscles, bladder and
      bowel functions. In this study, the investigators will investigate the efficacy of using FMS
      technique for respiratory muscle conditioning in patients with multiple sclerosis; and will
      compare the results of the expired functions (volume, pressure, and flow) generated by using
      the FMS technique with data obtained from using the resistive expiratory muscle training
      (REMT) methodology.
    

Intervention name(s): Functional Magnetic Stimulation; Resistive Expiratory Muscle Training
Intervention type(s): Other; Other
Intervention description(s): The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). A magnetic coil will be placed on participant's back to stimulate the nerves related to the breathing function. Each stimulation will last two seconds and the time between each stimulation is about half a minute. The training session will begin with low intensity FMS for 20 minutes daily. The FMS stimulation intensity will gradually increase during the 6-week training period.; The REMT training will take place in the FMS lab using a standard resistive breathing device. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Participants will wear a nose clip when performing the breathing exercise. The exercise protocol will begin with a low resistance level for 20 minutes a day. The resistance level will gradually increase during the 6-week training period.
Other intervention name(s): FMS; REMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Functional Magnetic Stimulation; Pulmonary Function