The Impact of Transcutaneous Electrical Stimulation on Facial Pain, Jaw Mobility, and Oral Health in Individuals With Motor Neuron Disease.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited) OR diagnosis of definite PLS by the treating neurologist and based on the consensus diagnostic criteria for PLS

• Subjective report of jaw pain, indicated by a NRS score of \> or = 3/10.

Locations
United States
Florida
Nova Southeastern University, David and Cathy Husman Neuroscience Institute
RECRUITING
Davie
Contact Information
Primary
Kayla Chomko, PT, DPT
kayla.chomko@nova.edu
954-817-5730
Backup
Raquel Garcia, SLP.D, CCC-SLP, BCS-S
rw602@nova.edu
954-914-5447
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-08-13
Participants
Target number of participants: 10
Treatments
Experimental: Transcutaneous electrical stimulation to reduce facial pain and improve jaw ROM in ALS and PLS.
All 10 participants will receive a single TENS intervention, with electrodes placed over the masseter and TMJ regions. This intervention is designed to evaluate TENS as a potential treatment for reducing facial pain and improving jaw mobility and chewing function in individuals with ALS and PLS..
Sponsors
Leads: Nova Southeastern University

This content was sourced from clinicaltrials.gov