Mechanical Cutaneous Nerve Stimulation for Reducing Epileptic Seizures and Perceived Pain (Case No. 2016-686-3)

Summary:

UCLA researchers have developed a novel, non-invasive pain management device that uses mechanical vibrations to activate cutaneous sensory fibers, reducing epileptic seizures, masking pain perception and alleviating associated symptoms. 

Background:

Unexpected death due to epilepsy is a pressing concern, with an estimated incidence of 1.2 per 1000 adults. Repeated seizures can lead to significant life-threatening complications such as repetitive excitotoxic, hypoxic, perfusion, and other critical brain injuries. Reducing seizure activity is of critical concern to prevent sudden unexpected deaths. Classical approaches to seizure intervention include a range of pharmaceutical agents or electrical stimulation. However, these offer varying degrees of effectiveness in reducing seizures, but often come with significant side effects. Electrical vagal nerve stimulation involves the invasive placement of electrodes or non-invasive electrical stimulations to portions of the external auricle. The success of these procedures varies widely from about 38-76% and carry risks for cutaneous injury, voice hoarseness, breathing complications, cough, and cardiovascular symptoms. These treatment options are like those utilized for regional pain and migraine treatment but carry the same risks and limitations as those treating epilepsy patients. Given these limitations in epileptic seizures management, there is an urgent need for an innovative, non-invasive solution that is both effective and easy to use for seizure management, without electrical injury to the skin, negative vagal effects on vocal cords, breathing, or cardiovascular activity. 

Innovation:

UCLA researchers have developed a novel, non-invasive procedure that uses precise mechanical vibrations at particular frequencies, instead of electrical stimulation, to activate cutaneous sensory fibers and mask pain perception. When applied to the sensory fields of the cranial and cervical nerves for the head, neck and shoulders, these vibratory stimuli can disrupt signaling in multiple ways. First, by interfering with transmission along common pain pathways, second, overwhelming pain signals by activating faster-conducting mechanoreceptor nerves, and third, in the case of chronic pain, disrupting thalamocortical circuitry involved in long-term pain processing. This patient-controlled technology allows users to adjust intensity, frequency and pulse pattern of the vibrations in real time, providing immediate relief and maximizing comfort. Additionally, the patient may have the option to use the device proactively, “training” the brain to suppress activity linked to future pain onset. This system can be used for direct electrical stimulation to reduce epileptic seizures by modifying neural action with the vibration motor. By offering a safe, non-invasive, and patient-controlled alternative to traditional pain management, this innovation fills a critical gap in treatment options, empowering individuals to take control of their pain without the risks and side effects of pharmaceuticals or invasive procedures. 

Potential Applications:

•    Pain relief of multiple conditions
-    Includes migraine pain; regional pain in the head, neck, shoulders, limbs, or other areas of the body; localized pain in joints of the leg or the feet. 
•    Reducing Epileptic Seizures
-    Vibratory stimulation signal can simulate proprioceptive nerves in the limb, triggering kinesthetic cures and eventually suppressing seizure activity.
•    Stroke intervention: devices can be placed to activate neurons in the regions affected by the stroke. 
-    The brain will find alternative ways, presumably by very small vessels, to serve those activated neurons. 
•    Assist cardiovascular, mood and epilepsy aspects: stimulating sensory components of the vagus nerve.
•    Atrial fibrillation and abnormal blood pressure: activating vagal fibers. 
•    Relieve breathing conditions: respiratory deficiencies, obstructive sleep apnea, periodic breathing, and hypoventilation. 
-    Also to “retrain” appropriate breathing patterns by providing appropriate sensory stimuli to cerebellar and brainstem respiratory motor regulatory areas. 
•    Treatment and alleviation of various head movement pathologies, epilepsy, anxiety, depression and post-traumatic stress. 

Advantages:

•    This device brings substantial relief of pain to a wide range of pain syndromes. 
-    Non-invasive: minimal medical intervention after initial instruction. 
-    Rapid: can reduce pain within minutes of administration, typically 10-20 minutes. 
•    This device avoids: 
-    Pharmaceutical agents: has no deleterious cognitive, arousal, mood or motoric side effects
-    Paralytic muscle agents (such as Botox)
-    Invasive surgery: poses no risk for tissue injury at the site of contact
•    This device is very small, allowing placement in multiple cutaneous sites simultaneously. 
-    Can be comfortably worn for long periods of time
-    Can be readily attached and removed without discomfort or injury to tissue

Development to Date:

•    Ancillary equipment (battery–powered current for the vibration devices) has been constructed and is ready for mass implantation. Devices for vibration have been custom-made for patients.
•    Clinical studies are underway with Institutional Review Board approval in a range of patients with pain and vascular issues.
•    Preliminary data suggest that appropriate and effective mechanical vibration stimulation substantially reduce pain in multiple sites of the head, neck, shoulders and legs. 
•    The technology has been patented under US20220211319A1 specifically for use in the treatment of epileptic seizures. This patent is titled “Non-invasive proprioceptive stimulation for treating epilepsy.”

Reference:

UCLA Case No. 2016-686-3

Publications:

Harper R.M., Hertling D., Curtis A., Sauerland E.K., De Giorgio C.M., Pilot Safety and Feasibility Study of Non-invasive Limb Proprioceptive Cerebellar Stimulation for Epilepsy, Front. Neurol. , 16 August 2021, https://doi.org/10.3389/fneur.2021.675947

Press Release: 

A dime-size buzzer on the foot could reduce epileptic seizures

Patent:

Non-invasive proprioceptive stimulation for treating epilepsy

Lead Inventor:

Ronald M. Harper, Eberhardt K. Sauerland
 

Patent Information:
For More Information:
Megha Patel
Business Development Officer
Megha.patel@tdg.ucla.edu
Inventors:
Ronald Harper
Eberhardt Sauerland
Christopher Degiorgio