Participants Needed for a Pilot Study of a New Diagnostic Device

Dr. Perry Mansfield at the SENTA Clinic in San Diego, Calif., is looking for healthy individuals and patients with neuromuscular disease who have documented neurologic pharyngeal muscle dysfunction (dysfunction of the voluntary muscles that form the pharynx) to participate in a pilot study. This study will help to prove the diagnostic consistency of transmembrane electromyography (TM-EMG) and needle electromyography (NEMG). The goal of this study is to measure the neuromuscular function in the deep throat muscles (pharyngeal muscles), which are responsible for speech and swallowing. If the researchers at Dr. Mansfield’s lab can show consistency and efficacy of EMG evaluation, this testing can be used in the future to diagnose and analyze the progression of neuromuscular disease in non-treated and treated patients, and during clinical trials. 

During the first visit, patients will undergo a physical exam that determines participants’ eligibility for the study. During the second visit, the doctor will record TM-EMG and NEMG for approximately five seconds in four locations. The results will be sent off site for analysis to determine the efficacy of the TM-EMG probe.

To be eligible to participate, individuals between 18 and 70 years old must meet the criteria for one of the three cohorts listed below:

  • Cohort 1: documented neurological disorders, including amyotrophic lateral sclerosis (ALS) and muscular dystrophy, involving upper airway striated muscles and the presence of bulbar symptoms.
  • Cohort 2: moderate to severe sleep apnea (OSA), proven by an in-lab polysomnogram (PSG), including:
    • An Apnea-Hypopnea Index score, which indicates the severity of sleep apnea, > 25
    • A nocturnal oxygen saturation score < 85%
    • No use of continuous positive airway pressure (CPAP)
  • A cohort of healthy participants with:
    • Normal craniofacial anatomy
    • A body-mass index (BMI) < 30

Travel assistance is not available for this study.

If you live in the San Diego area, contact Derrick Cordice at 619-810-1239 or dcordice@sentaclinic.com to inquire about participation. To find out more information about the study, you may also visit https://clinicaltrials.gov/ct2/show/NCT03986671.

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