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

NCT03986671 | Completed Results FDA Device

• 1 other identifier: TM-EMG Pilot Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EMG Testing

EXPERIMENTAL

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

Interventions

Transmembrane EMG Oropharynx Probe 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).

EMG Testing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to topical anesthetic
• 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

Sponsors & Collaborators

• Powell Mansfield Inc.: lead

Study Sites (1)

SENTA Clinic

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Amyotrophic Lateral Sclerosis; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Chris Studer
• Organization: Powell Mansfield Inc.

cstuder@powellmansfield.com

6198101000

Study Officials

• Perry Mansfield, MD

  Perry Mansfield MD Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 14, 2019
• Study Start: April 30, 2019
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)