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.
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.
history of head or neck cancer
history of CVA
history of past facial surgery with hardware placement
history of pacemaker
Single group
Transcutaneous Electrical Nerve Stimulation to reduce facial pain and improve jaw range of motion in ALS and PLS
DeviceTENS 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.
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.
Jaw Range of Motion (jROM) Assessment
Maximum interincisal distance (MID) and Maximal lateral jaw movement will be measured utilizing the TheraBite range of motion scale. The participant will be instructed to open their mouth as wide as possible within a pain-free range. The TheraBite ROM Scale will be positioned between the upper and lower central incisors, and the maximum opening will be measured in millimeters (mm). The participant will be instructed to move their jaw sideways to the left and right within a pain-free range. The TheraBite ROM Scale will be used to measure the distance between the midline of the upper and lower teeth, with the values recorded in millimeters (mm). A surface EMG sensor will be positioned on the masseter muscle belly during both jROM assessments to measure muscle activity at rest, during passive stretch and during muscle activation. This will provide real-time data visualization to quantify muscle activation patterns pre- and post- intervention.
Test of Mastication and Swallowing Solids (TOMASS)
The TOMASS will be utilized to assess solid bolus ingestion by quantifying masticatory efficiency, speed, and safety, providing objective measurements of mastication performance. The TOMASS allows clinicians to capture detailed information about the relationship between jaw function, pain, and mastication issues when consuming a standardized solid food item (saltine cracker). The objective outcomes include the number of masticatory cycles and swallows per bite, and duration.
Numeric Rating Scale for Oral Hygiene
Patient-reported difficulty completing oral hygiene will be assessed using a NRS ranging from 0 (no difficulty) to 10 (significant difficulty). Participants will rate their perceived difficulty by providing a number from 0 (no difficulty) to 10 (significant difficulty).
Oral Transit Time (OTT)
In the event the participant cannot chew a saltine cracker, required for the TOMASS, the OTT will be utilized. The OTT is a tool to quantify how many seconds it takes a participant to consume a modified textured food item (IDDSI level 4, apple sauce) and clear bolus from oral cavity. OTT will be described using quantitative parameters from the Mann Assessment of Swallowing Ability (MASA): Score of 2 = No oral transit movement observed; Score of 4 = delay \>10 seconds ; Score of 6 =delay \> 5 seconds; Score of 8 = delay \>1 second; Score of 10 = no OTT delay.
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