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

NCT ID: NCT03986671

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-03-26

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.

Conditions

Obstructive Sleep Apnea; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Transmembrane EMG Oropharynx Probe

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Powell Mansfield Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perry Mansfield, MD

Role: PRINCIPAL_INVESTIGATOR

Perry Mansfield MD Inc.

Locations

SENTA Clinic

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TM-EMG Pilot Study

Identifier Type: -

Identifier Source: org_study_id