Electrical stimulation to reduce facial pain and improve jaw movement and chewing 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.
This trial will try one 30-minute session of non-invasive facial electrical stimulation to see if it reduces jaw and facial pain and improves chewing and jaw movement for people with ALS or PLS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 1 site (Davie, Florida) |
| Trial ID | NCT07187388 on ClinicalTrials.gov |
What this trial studies
Participants with ALS or PLS who report jaw or facial pain will attend one in-person clinic visit for pre-intervention measures, receive a single 30-minute transcutaneous electrical nerve stimulation (TENS) session applied to facial muscles, and then complete identical post-intervention assessments; a brief telephone interview will be done 24 hours later. Primary measures include patient-reported jaw/facial pain on a numeric rating scale, while secondary measures include jaw range of motion, chewing efficiency (using a saltine cracker test), and perceived difficulty with oral hygiene tasks. The PI or Co-PI will monitor the session and participants can stop the intervention at any time if they experience discomfort. The visit is expected to last about 90 minutes and this is a single-session, prospective cross-sectional intervention.
Who should consider this trial
Good fit: Ideal candidates are people diagnosed with possible/probable/definite ALS or definite PLS who report jaw or facial pain of 3/10 or higher and who do not have excluded conditions like pacemakers, active head/neck cancer, seizures, open wounds at electrode sites, or complete sensory loss in the electrode area.
Not a fit: People without jaw or facial pain, those with complete loss of sensation at the electrode site, or those who meet exclusion criteria such as pacemaker presence, prior head/neck hardware, recent stroke, or uncontrolled seizures are unlikely to benefit or are not eligible for this intervention.
Why it matters
Potential benefit: If successful, this could offer a simple, non-drug way to reduce facial/jaw pain and improve jaw movement, chewing, and ease of oral care for people with ALS or PLS.
How similar studies have performed: TENS and other non-invasive electrical stimulation methods have shown pain-relief benefits in various musculoskeletal and facial pain conditions, but their use for jaw pain specifically in ALS/PLS is not well studied and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Davie, Florida
- Nova Southeastern University, David and Cathy Husman Neuroscience Institute — Davie, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Kayla Chomko, PT, DPT
- Email: kayla.chomko@nova.edu
- Phone: 954-817-5730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.