Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01758224
First received: December 19, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention
Multiple Sclerosis
Other: Functional Magnetic Stimulation
Other: Resistive Expiratory Muscle Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Pulmonary Function Testing (PFT) [ Time Frame: At study initiation and every two weeks over a 14 week period (8 PFTs) ] [ Designated as safety issue: No ]
    Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).


Estimated Enrollment: 8
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Magnetic Stimulation
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).
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 Name: FMS
Active Comparator: Resistive Expiratory Muscle Training
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.
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.
Other Name: REMT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758224

Contacts
Contact: Vernon W Lin, MD PhD 216 445-7350 linv@ccf.org
Contact: Xiaoming Zhang, PhD 216 445-7647 zhangx6@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Vernon W Lin, MD PhD    216-445-7350    linv@ccf.org   
Contact: Xiaoming Zhang, PhD    216 445-7647    zhangx6@ccf.org   
Principal Investigator: Vernon W Lin, MD PhD         
Sub-Investigator: Xiaoming Zhang, PhD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Vernon W Lin, MD PhD The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01758224     History of Changes
Other Study ID Numbers: W81XWH-11-1-0707
Study First Received: December 19, 2012
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by The Cleveland Clinic:
Multiple Sclerosis
Functional Magnetic Stimulation
Pulmonary Function

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014