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Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986671
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Powell Mansfield Inc.

Study Description
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Brief Summary:
This is a pilot study to examine the diagnostic utility of a novel transmembrane surface sensor, and compare signals obtained with the transmembrane sensor to conventional needle EMG signals from healthy volunteers to those with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy) and to those with severe OSA.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Amyotrophic Lateral Sclerosis Muscular Dystrophies Healthy Device: Transmembrane EMG Oropharynx Probe Not Applicable

Detailed Description:
Transmembrane electromyography (TM-EMG) may be a feasible and valid non-invasive EMG technique for detecting neuromuscular (NM) impairment. This study will assess whether, in healthy volunteers and participants with known obstructive sleep apnea (OSA) and other NM diseases involving the oropharynx, the same characteristic motor unit potentials obtained on conventional needle EMG (NEMG) can be obtained using a TM-EMG sensor. The purpose of this study is to demonstrate whether the TM-EMG sensor can provide the same diagnostic accuracy as the concentric needle electrode for the diagnosis of NM diseases. Having demonstrated diagnostic similarity of TM-EMG to NEMG, the secondary aim of this study is to confirm that NM disturbance of oropharyngeal striated muscles in participants with OSA can be elicited with the TM-EMG sensor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, cohort, pilot study with blinded data analysis and two physician testers to assess intertester reliability and device usability. Volunteers will include healthy adults, participants with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy), and participants with severe OSA. For each participant diagnostic properties of EMG studies will be assessed using a conventional needle and TM-EMG sensor in pharyngeal muscles.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: EMG Testing
Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmenbrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).
 Device: Transmembrane EMG Oropharynx Probe
Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmembrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).


Outcome Measures
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Primary Outcome Measures :
  1. Proof of Diagnostic Consistency [ Time Frame: 1 hour ]
    Proof of diagnostic consistency using both the TM-EMG sensor and NEMG in neuromuscular disorders of the oropharyngeal muscles.


Secondary Outcome Measures :
  1. Neuromuscular function in OSA Participants versus Healthy Participants [ Time Frame: 1 hour ]
    Comparison of EMG data collected from OSA Participants and Healthy Participants


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-70
  • Must be able to pause use of anticoagulation, NSAID and multi-vitamins for appropriate period prior to study test.
  • Must be willing to stop any type of smoking or vaping 10 days prior to testing

A cohort of participants with documented neurological disorders involving upper airway striated muscles including ALS and muscular dystrophy with the presence of bulbar symptoms.

A cohort of participants diagnosed with moderate to severe OSA proven by an in-lab PSG, including the following criteria:

  • AHI > 25
  • Nadir SaO2 < 85%
  • not currently using CPAP

A cohort of healthy participants that meet the following criteria:

  • Normal craniofacial anatomy
  • BMI < 30

Exclusion Criteria:

  • Allergy to topical anesthetic
  • 4 or more alcoholic drinks on the same occasion on 5 or more days in the past month
  • Prior cancer, or radiation to the head or neck
  • Craniofacial anatomical disorders
  • Presence of any underlying medical, surgical or psychiatric disorder that would preclude participation as determined by the principal investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986671


Contacts
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Contact: Derrick Cordice 619-810-1239 dcordice@sentaclinic.com

Locations
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United States, California
SENTA Clinic Recruiting
San Diego, California, United States, 92108
Principal Investigator: Perry T Mansfield, MD         
Sponsors and Collaborators
Powell Mansfield Inc.
Investigators
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Principal Investigator: Perry Mansfield, MD Perry Mansfield MD Inc.
More Information
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Responsible Party: Powell Mansfield Inc.
ClinicalTrials.gov Identifier: NCT03986671    
Other Study ID Numbers: TM-EMG Pilot Study
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Sleep Apnea, Obstructive
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
 Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn