NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.
| NCT ID | NCT07187388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Southeastern University |
| Condition | Amyotrophic Lateral Sclerosis (ALS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2026-08-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-04-02 with a primary completion date of 2026-08-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07187388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis (ALS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07187388 currently recruiting?
Yes, NCT07187388 is actively recruiting participants. Contact the research team at kayla.chomko@nova.edu for enrollment information.
Where is the NCT07187388 trial being conducted?
This trial is being conducted at Davie, United States.
Who is sponsoring the NCT07187388 clinical trial?
NCT07187388 is sponsored by Nova Southeastern University. The trial plans to enroll 10 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.