Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation



Status:Completed
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:4/2/2016
Start Date:September 2012
End Date:September 2014
Contact:Vernon W Lin, MD PhD
Email:linv@ccf.org
Phone:216 445-7350

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Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis

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.

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.

Inclusion Criteria:

- Multiple Sclerosis diagnosis

- Baseline maximal expiratory pressure (MEP) values between 50% and 70% of predicted
values

- Patients must also be in stable condition and free of active brain disease or
cardiovascular disorders (history of myocardial infarction, congestive heart disease,
or uncontrolled hypertension).

Exclusion Criteria:

- Cardiac pacemakers, ferromagnetic metal implants, uncontrolled high blood pressure,
active pulmonary conditions such as chronic obstructive pulmonary disease,
bronchiectasis, asthma, and diaphragmatic paralysis.

- Patients who are ventilator dependent, with significant scoliosis, other chest wall
deformity, obesity, severe diabetes mellitus, as well as pregnant women will be
excluded from participating in the study.

- Patients with substance abuse or mental incompetence will also be excluded.
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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