NCT07187388Recruiting
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.
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 2 Apr 2026
- Primary completion date
- 13 Aug 2026
- Lead sponsor
- Nova Southeastern University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07187388
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 2 Apr 2026 to the primary completion date, 13 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- open wound at the area of electrode placement
- complete loss of sensation at the area of electrode placement
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nova Southeastern University, David and Cathy Husman Neuroscience Institute Coordinator of this site? Confirm its status | Davie | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.