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Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Magnetic Stimulation
Resistive Expiratory Muscle Training
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Functional Magnetic Stimulation, Pulmonary Function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional Magnetic Stimulation

Resistive Expiratory Muscle Training

Arm Description

This group will receive magnetic stimulation of the respiratory (breathing) muscles that may improve the breathing function in subjects with MS. The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes).

Participants in this group will perform breathing exercises using a resistive breathing device. The training will take place in the FMS lab. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home.

Outcomes

Primary Outcome Measures

Pulmonary Function Testing (PFT)
Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).

Secondary Outcome Measures

Full Information

First Posted
December 19, 2012
Last Updated
August 2, 2016
Sponsor
The Cleveland Clinic
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01758224
Brief Title
Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation
Official Title
Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 FMS conditioning of the expiratory muscles can generate significant expiratory flows and pressures in patients with MS. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Functional Magnetic Stimulation, Pulmonary Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Magnetic Stimulation
Arm Type
Experimental
Arm Description
This group will receive magnetic stimulation of the respiratory (breathing) muscles that may improve the breathing function in subjects with MS. The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes).
Arm Title
Resistive Expiratory Muscle Training
Arm Type
Active Comparator
Arm Description
Participants in this group will perform breathing exercises using a resistive breathing device. The training will take place in the FMS lab. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home.
Intervention Type
Other
Intervention Name(s)
Functional Magnetic Stimulation
Other Intervention Name(s)
FMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistive Expiratory Muscle Training
Other Intervention Name(s)
REMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Function Testing (PFT)
Description
Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).
Time Frame
At study initiation and every two weeks over a 14 week period (8 PFTs)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vernon W Lin, MD PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11239305
Citation
Lin VW, Hsiao IN, Zhu E, Perkash I. Functional magnetic stimulation for conditioning of expiratory muscles in patients with spinal cord injury. Arch Phys Med Rehabil. 2001 Feb;82(2):162-6. doi: 10.1053/apmr.2001.18230.
Results Reference
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PubMed Identifier
10548207
Citation
Singh H, Magruder M, Bushnik T, Lin VW. Expiratory muscle activation by functional magnetic stimulation of thoracic and lumbar spinal nerves. Crit Care Med. 1999 Oct;27(10):2201-5. doi: 10.1097/00003246-199910000-00022.
Results Reference
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Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation

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