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出境医 / 临床实验 / Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

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

Study Description
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)
Actual Enrollment : 52 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
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : March 26, 2021
Arms and Interventions
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
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

Locations
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United States, California
SENTA Clinic
San Diego, California, United States, 92108
Sponsors and Collaborators
Powell Mansfield Inc.
Investigators
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Principal Investigator: Perry Mansfield, MD Perry Mansfield MD Inc.
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE April 30, 2019
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Neuromuscular function in OSA Participants versus Healthy Participants [ Time Frame: 1 hour ]
Comparison of EMG data collected from OSA Participants and Healthy Participants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
Official Title  ICMJE A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Amyotrophic Lateral Sclerosis
  • Muscular Dystrophies
  • Healthy
Intervention  ICMJE 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).
Study Arms  ICMJE 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).
Intervention: Device: Transmembrane EMG Oropharynx Probe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2021) 		52
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		23
Actual Study Completion Date  ICMJE March 26, 2021
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986671
Other Study ID Numbers  ICMJE TM-EMG Pilot Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Powell Mansfield Inc.
Study Sponsor  ICMJE Powell Mansfield Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Perry Mansfield, MD Perry Mansfield MD Inc.
PRS Account Powell Mansfield Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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