Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia

NCT05158179 | Completed Results FDA Device

• 1 other identifier: IRB: 20-31653
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Study investigators have completed a study testing laryngopharyngeal sensation at specific laryngopharyngeal subsites using a novel buckling force aesthesiometer in a series of 22 healthy adults at this institution. Investigators would like to use the same device apparatus to evaluate laryngopharyngeal sensation in patients with laryngopharyngeal disorders, such as adductor spasmodic dysphonia. This study will use a tested laryngopharyngeal aesthesiometer to examine laryngeal sensation using calibrated tactile stimuli to determine differences in somatotopic perceptual strength maps of laryngopharyngeal structures between patients with laryngopharyngeal disorders and healthy controls.

Conditions

Spasmodic Dysphonia; Adductor Spasmodic Dysphonia; Voice Disorders

Keywords

throat sensation

Outcome Measures

Primary Outcomes (1)

• Laryngeal Adductor Reflex

  The outcome measure is the presence or absence of a laryngeal adductor reflex (LAR) which is the reflexive, involuntary closure of the vocal folds in response to stimulation, as seen on flexible laryngoscopy. This is a binary finding in that this is immediately observed as either being present or absent following direct contact by the tactile esthesiometer device. Accordingly, there are no units of measure. The presence or absence of the LAR was noted at the time of testing by the study team and confirmed on subsequent video review by another member of the study team. This study only examined patients with SD - all of whom were found to have LAR present.

  Immediately after intervention, less than 10 seconds

Secondary Outcomes (1)

• Perceptual Strength of Sensation on a 1-10 Numerical Rating Scale (NRS)

  Immediately after intervention, within 30 seconds

Study Arms (1)

Spasmodic Dysphonia Patients

EXPERIMENTAL

Following appropriate nasal local anesthetic, the channeled laryngoscope was inserted through the nose. The 6-0 monofilament was pressed against the posterior nasopharyngeal wall and swiftly removed to establish a perceptual strength of "1", as an internal anchor. The lateral pyriform sinus (LPS) was presented with the planned stimulus, followed by the aryepiglottic fold (AEF) and the false vocal folds (FVF). Participants were instructed to raise their hand when the stimulus was detected, and then were asked by the study team to report a perceptual strength "score," in comparison to the nasopharyngeal anchor strength of 1. LAR response was recorded by the study team. A negative response was defined as a lack of LAR to two appropriate stimuli. The LPS and AEF were tested in order of increasing stimulus: 6-0, 5-0, 4.5-0 and 4-0 monofilaments. The false vocal folds (FVF) were tested last. Testing of FVF terminated after the first observed LAR.

Device: Sensation testing

Interventions

Sensation testing DEVICE

Sensation testing tactile aesthesiometer.

Spasmodic Dysphonia Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adductor spasmodic dysphonia (can have co-diagnosis of essential tremor)
• received Botox injection more than 2 weeks ago

You may not qualify if:

• excessive gagging
• active smoker
• non-Botox responsive
• abductor spasmodic dysphonia exclusively
• essential tremor diagnosis exclusively

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Spasmodic Dysphonia Association: collaborator

Study Sites (1)

UCSF Voice and Swallowing Center

San Francisco, California, 94115, United States

Location

Related Publications (5)

• Bearelly S, Cheung SW. Sensory Topography of Oral Structures. JAMA Otolaryngol Head Neck Surg. 2017 Jan 1;143(1):73-80. doi: 10.1001/jamaoto.2016.2772.

  PMID: 27684535 BACKGROUND

• Bearelly S, Wang SJ, Cheung SW. Oral sensory dysfunction following radiotherapy. Laryngoscope. 2017 Oct;127(10):2282-2286. doi: 10.1002/lary.26591. Epub 2017 Apr 11.

  PMID: 28397276 BACKGROUND

• Aviv JE, Martin JH, Keen MS, Debell M, Blitzer A. Air pulse quantification of supraglottic and pharyngeal sensation: a new technique. Ann Otol Rhinol Laryngol. 1993 Oct;102(10):777-80. doi: 10.1177/000348949310201007.

  PMID: 8215097 BACKGROUND

• Aviv JE, Martin JH, Kim T, Sacco RL, Thomson JE, Diamond B, Close LG. Laryngopharyngeal sensory discrimination testing and the laryngeal adductor reflex. Ann Otol Rhinol Laryngol. 1999 Aug;108(8):725-30. doi: 10.1177/000348949910800802.

  PMID: 10453777 BACKGROUND

• Strohl MP, Young VN, Dwyer CD, Bhutada A, Crawford E, Chang JL, Rosen CA, Cheung SW. Novel Adaptation of a Validated Tactile Aesthesiometer to Evaluate Laryngopharyngeal Sensation. Laryngoscope. 2021 Jun;131(6):1324-1331. doi: 10.1002/lary.28947. Epub 2020 Jul 31.

  PMID: 32735711 BACKGROUND

MeSH Terms

Conditions

Dysphonia; Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Yue Ma
• Organization: University of California San Francisco

yue.ma@ucsf.edu

415-885-7700

Study Officials

• Yue Ma, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Cottonoid pledgets soaked in 4% lidocaine and neo-synephrine will be placed on this side. The pledgets will be kept in place for 5 minutes to allow adequate decongestion and anesthetization. The aesthesiometer will be placed through the 2.0 mm working channel of the Olympus Corporation (Tokyo, Japan) ENF-VT2 channeled flexible video rhinolaryngoscope with a 4.9 mm outer diameter. The flexible laryngoscope and aesthesiometer assembly will then be advanced into the pharynx and positioned for target testing. The operator field of view will be adjusted in the craniocaudal axis to optimize visualization of the stimulation target, monofilament tip, and both vocal folds to assess for a stimulation evoked LAR response. The monofilament will then be advanced to within several mm of the target laryngopharyngeal subsite and subsequently applied orthogonally until it buckled by 10-30%, followed by quick retraction to assess for triggering of the rapid LAR response.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 15, 2021
• Study Start: August 27, 2021
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)