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

Part of paid clinical trials in Davie, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT07187388
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 2, 2026
Status verified
May 2026
Primary completion
Aug 13, 2026
Completion
Aug 13, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Numerical Rating Scale for Pain [ Time Frame: Baseline, immediately post-intervention and 24 hours post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern University, David and Cathy Husman Neuroscience InstituteDavieFlorida33314
Kayla Chomko, PT, DPT
[email protected]
954-817-5730
Raquel Garcia, SLP.D, CCC-SLP, BCS-S
[email protected]
954-914-5447

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By research site
Nova Southeastern University, David and Cathy Husman Neuroscience Institute· Davie, FL

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