A new clinical trial sponsored by Nova Southeastern University is investigating the use of Transcutaneous Electrical Nerve Stimulation (TENS) to manage facial pain, enhance jaw movement, and improve oral health in patients suffering from Motor Neuron Disease (MND), including Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). This innovative approach could address significant quality of life challenges faced by individuals living with these progressive conditions.
In this article:
- What changed?
- How is TENS applied?
- Clinical trial details
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement Link
What changed?
The trial, which is currently recruiting participants, introduces TENS—a device-based intervention aimed at addressing symptoms often overlooked in MND care. TENS is already widely recognized for managing nerve-related pain in other conditions, but its specific application for facial pain and jaw limitations caused by ALS or PLS is novel.
For regulatory and clinical teams monitoring advancements in medical devices, this investigation emphasizes a targeted approach tailored to neuromuscular diseases.
How is TENS applied?
TENS works through the delivery of low-voltage electrical stimulation via electrodes placed on the skin. The device targets nerve pathways associated with pain and movement control, promoting relief and potentially improving range of motion.
Its use in this trial involves customization based on the needs and symptoms of individuals diagnosed with ALS or PLS. By focusing specifically on managing facial discomfort and jaw mobility, TENS may provide complementary benefits to traditional therapies.
Clinical trial details
The trial is being conducted under the stewardship of Nova Southeastern University, which is actively recruiting participants as of October 5, 2025. Researchers aim to explore whether routine application of TENS can improve oral health outcomes alongside pain reduction and increased jaw function.
Conditions studied:
- Amyotrophic Lateral Sclerosis (ALS)
- Primary Lateral Sclerosis (PLS)
- Motor Neuron Disease
Intervention:
- Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Professionals in regulatory affairs may find interest in how device performance and safety are being documented in the specific context of neuromuscular diseases.
Further information can be accessed directly via the study’s unique identifier: NCT07187388.
Frequently Asked Questions
- Who is eligible for the trial?
Individuals who have been diagnosed with ALS or PLS may qualify for participation. Details on inclusion criteria can be found on the trial’s official webpage linked below. - How does TENS improve jaw function?
The electrical stimulation promotes nerve activity that may lead to better muscle coordination and mobility in the jaw area. - Is TENS approved for use in other conditions?
Yes, TENS is widely used for pain management in other conditions, but researchers are exploring its efficacy specifically for MND-related symptoms in this trial.
Conclusion
This ongoing clinical trial showcases an innovative use of TENS technology to address facial pain and jaw function limitations in ALS and PLS patients. It represents a critical step toward enhancing care for individuals with motor neuron diseases. Clinical and regulatory teams can monitor this trial to evaluate its implications for device safety and performance regulations.
Disclaimer
This article is intended for informational purposes only and should not be viewed as legal or medical advice. Readers are encouraged to consult official regulatory sources for compliance-related inquiries.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07187388?term=medical+device