RECRUITING

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-11-01
Study Completion:2026-08-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07187388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Subjective report of jaw pain, indicated by a NRS score of \> or = 3/10.
  1. * history of head or neck cancer
  2. * history of CVA
  3. * history of past facial surgery with hardware placement
  4. * history of pacemaker
  5. * diagnosis of significant cognitive impairment by the treating physician
  6. * history of seizures or diagnosis of epilepsy
  7. * open wound at the area of electrode placement
  8. * complete loss of sensation at the area of electrode placement

Contacts and Locations

Study Contact

Kayla Chomko, PT, DPT
CONTACT
954-817-5730
kayla.chomko@nova.edu
Raquel Garcia, SLP.D, CCC-SLP, BCS-S
CONTACT
954-914-5447
rw602@nova.edu

Study Locations (Sites)

Nova Southeastern University, David and Cathy Husman Neuroscience Institute
Davie, Florida, 33314
United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11-01
Study Completion Date2026-08-13

Study Record Updates

Study Start Date2025-11-01
Study Completion Date2026-08-13

Terms related to this study

Keywords Provided by Researchers

  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
  • ALS
  • PLS
  • Motor Neuron Disease
  • MND
  • Facial Pain
  • jaw pain

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis (ALS)
  • Primary Lateral Sclerosis (PLS)
  • Motor Neuron Disease, Amyotrophic Lateral Sclerosis