Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07187388

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

Led by Nova Southeastern University · Updated on 2025-12-04

10

Participants Needed

1

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the impact of non-invasive electrical stimulation, when placed on the facial muscles can reduce facial pain and improve jaw mobility, and chewing in individuals with Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). The secondary goal is to evaluate the impact of non-invasive electrical stimulation on patient reported difficulty performing oral hygiene tasks in individuals with ALS and PLS. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention assessments, a single 30-minute treatment of electrical stimulation followed by post-intervention assessments. The assessments will include a self-rating of jaw and facial pain, a range of motion test where participants will be asked to open their jaw as wide and as far to the side as possible, and a chewing efficiency test using a saltine cracker. Twenty-four hours later, participants will receive a follow-up phone call to self-rate their facial pain and report any difficulty performing oral hygiene tasks. The treatment consists of a single 30-minute electrical stimulation session. Electrode pads will be placed on the participant's facial region, specifically over the masseter muscle belly and the TMJ area, while the participant is seated comfortably. The pads will be connected to an FDA-approved electrical stimulator, and the current will be adjusted to the participant's comfort level. Once set, the participant will remain seated for 30 minutes. At the end of the session, the stimulator will be turned off and the electrode pads removed.

CONDITIONS

Official Title

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of possible, probable, or definite ALS according to El-Escorial Revisited criteria or diagnosis of definite PLS by a neurologist based on consensus criteria
  • Report of jaw pain with a numeric rating scale score of 3 or greater
  • Age between 25 and 90 years
Not Eligible

You will not qualify if you...

  • History of head or neck cancer
  • History of cerebrovascular accident (stroke)
  • Past facial surgery involving hardware placement
  • Presence of a pacemaker
  • Diagnosis of significant cognitive impairment
  • History of seizures or epilepsy
  • Open wound at the electrode placement area
  • Complete loss of sensation at the electrode placement area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nova Southeastern University, David and Cathy Husman Neuroscience Institute

Davie, Florida, United States, 33314

Actively Recruiting

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Research Team

K

Kayla Chomko, PT, DPT

CONTACT

R

Raquel Garcia, SLP.D, CCC-SLP, BCS-S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. | DecenTrialz