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

NCT07187388 | Recruiting DMC FDA Device

• 1 other identifier: 2025-356-NSU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale for Pain

  0-10 numeric rating scale where participants will self rate their pain on a scale of 0-10 with 0 = no pain and 10 = worst possible pain.

  Baseline, immediately post-intervention and 24 hours post-intervention

Secondary Outcomes (3)

• Jaw Range of Motion (jROM) Assessment

  Baseline and immediately post-intervention

• Test of Mastication and Swallowing Solids (TOMASS)

  Baseline and immediately post-intervention

• Numeric Rating Scale for Oral Hygiene

  Baseline and 24 hours post intervention.

Other Outcomes (1)

• Oral Transit Time (OTT)

  Baseline and immediately post-intervention

Study Arms (1)

Transcutaneous electrical stimulation to reduce facial pain and improve jaw ROM in ALS and PLS.

EXPERIMENTAL

All 10 participants will receive a single TENS intervention, with electrodes placed over the masseter and TMJ regions. This intervention is designed to evaluate TENS as a potential treatment for reducing facial pain and improving jaw mobility and chewing function in individuals with ALS and PLS..

Device: Transcutaneous Electrical Nerve Stimulation to reduce facial pain and improve jaw range of motion in ALS and PLS

Interventions

Transcutaneous Electrical Nerve Stimulation to reduce facial pain and improve jaw range of motion in ALS and PLS DEVICE

TENS intervention will be administered using a current-controlled TENS device that produces charge-balanced, symmetrical biphasic rectangular pulses. Participants will be seated and skin cleaned prior to applying 2 self-adhesive round surface electrodes (25mm) on each side of the face. One electrode (anode) will be placed over the masseter muscle belly, while the other (cathode) will be positioned over the TMJ. Electrode placement will be confirmed by palpation of the TMJ and Masseter. This set up will be mirrored on the opposite side. Once all 4 electrodes are in place, the TENS unit will be turned on. Participants will remain seated. The TENS unit will be set to manual mode to deliver the stimulation at a frequency of 50 Hertz (Hz) and a pulse width of 200 microseconds (µseconds). Stimulation amplitudes will be gradually increased from 0 milliamps (mA) to each participant's tolerance level. The 30 minute TENS intervention will then take place.

Transcutaneous electrical stimulation to reduce facial pain and improve jaw ROM in ALS and PLS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University, David and Cathy Husman Neuroscience Institute

Davie, Florida, 33314, United States

RECRUITING

Related Publications (3)

• Alizadeh A, Karagah A, Tabrizi R, Shadman L, Arjmand A, Tofangchiha M, Patini R. Effect of transcutaneous electrical nerve stimulation on pain, edema, and trismus after surgical removal of impacted third molars: a split-mouth randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2024 Mar 1;29(2):e211-e218. doi: 10.4317/medoral.26193.

  PMID: 37823292 BACKGROUND

• Zayan K, Felix ER, Galor A. Transcutaneous Electrical Nerve Stimulation for Facial Pain. Prog Neurol Surg. 2020;35:35-44. doi: 10.1159/000509620. Epub 2020 Jul 21.

  PMID: 32694253 BACKGROUND

• Shanavas M, Chatra L, Shenai P, Rao PK, Jagathish V, Kumar SP, Naduvakkattu B. Transcutaneous electrical nerve stimulation therapy: An adjuvant pain controlling modality in TMD patients - A clinical study. Dent Res J (Isfahan). 2014 Nov;11(6):676-9.

  PMID: 25540662 BACKGROUND

Related Links

• Link to TENS device utilized
• EMG surface sensor

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Facial Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): August 13, 2026
• Study Completion (Estimated): August 13, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD will be available 12 months after publication of the primary results and for a period of 5 years.
• Access Criteria: De-identified IPD will be shared with qualified researchers upon reasonable request, subject to review by the study investigators and execution of a data use agreement.

Locations

US (1)