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

CompletedNot a drug-phase studyMS (type not specified)NCT01758224

What it found

No results found

We found no results in the registry or in papers.

This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Functional Magnetic Stimulation

Compared with

  • Resistive Expiratory Muscle Training

What it measured

Main measures

  • Pulmonary Function Testing (PFT)

    At study initiation and every two weeks over a 14 week period (8 PFTs)

Who could take part

MS (type not specified) · 18 to 70

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2012

    2. Main results due

      Sept 2015

    3. Finished

      Sept 2015

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