A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS, Obstructive Sleep Apnea, Muscular Dystrophies

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Perry Mansfield, MD Perry Mansfield MD Inc.

Clinicaltrials.gov ID (11 digit #):

NCT03986671

Neals Affiliated?

Coordinating Center Contact Information

SENTA Clinic
Derrick Cordice / .(JavaScript must be enabled to view this email address) / 619-810-1239
.(JavaScript must be enabled to view this email address) San Diego, California 92108 United States

Full Study Summary:

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 Sponsor:

Powell Mansfield Inc.

Participant Duration:

Estimated Enrollment:

Estimated Study Start Date:

04/30/2019

Estimated Study Completion Date:

04/30/2020

Posting Last Modified Date:

10/31/2021

Date Study Added to alsconsortium.org:

07/25/2019

Eligibility Criteria
Gender:
Female, Male
Minimum Age:
18
Maximum Age:
70

Time since Symptom Onset:
N/A
Time since Diagnosis:
N/A
Can participants use Riluzole?
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
Site Contact Information

SENTA Clinic
San Diego, California 92108
United States