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Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.
The Impact of Transcutaneous Electrical Stimulation on Facial Pain, Jaw Mobility, and Oral Health in Individuals With Motor Neuron Disease.
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * history of head or neck cancer * history of CVA * history of past facial surgery with hardware placement * history of pacemaker * diagnosis of significant cognitive impairment by the treating physician * history of seizures or diagnosis of epilepsy * open wound at the area of electrode placement * complete loss of sensation at the area of electrode placement
About the study
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.
What is being tested
- Transcutaneous Electrical Nerve Stimulation to reduce facial pain and improve jaw range of motion in ALS and PLS (device)
Sponsor: Nova Southeastern University · Participants: 10 · Started: Apr 2, 2026
Contact the study team
- Kayla Chomko, PT, DPT · Phone: 954-817-5730
- Raquel Garcia, SLP.D, CCC-SLP, BCS-S · Phone: 954-914-5447
Official record on ClinicalTrials.gov — NCT07187388
Locations in the U.S.
| Florida | Nova Southeastern University, David and Cathy Husman Neuroscience Institute, Davie |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.