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Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation

NCT01758224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-08-04

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Functional Magnetic Stimulation

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.

OTHER

Resistive Expiratory Muscle Training

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Vernon W Lin, MD PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758224 on ClinicalTrials.gov