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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986671
• Other study ID #: TM-EMG Pilot Study
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: March 26, 2021

Study information

• Verified date: June 2022
• Source: Powell Mansfield Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Healthy
• Motor Neuron Disease
• Muscular Dystrophies
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
United States	SENTA Clinic	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Powell Mansfield Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proof of Diagnostic Consistency	Proof of diagnostic consistency using both the TM-EMG sensor and NEMG in neuromuscular disorders of the oropharyngeal muscles. Significant Inter rater reliability between two blinded neuromuscular experts when using TM-EMG in the palatoglossal and genioglossus.	1 hour