Chronic pain and other persistent medical conditions often present challenges to achieving effective therapy. Too often the long-term use of medications, such as painkillers, poses health risks, including adverse off-target effects, the development of drug resistance over time, or potential drug dependency. Recent developments in the field of bioelectric medicine aim to address chronic pain and other neurological conditions, using nerve stimulation as an alternative to pharmaceuticals.
Bioelectric medicine employs devices to read and temper electrical activity in the nervous system, enabling real-time treatment with potentially fewer side effects than drug-based therapies. Bioelectric treatment approaches have been launched for several conditions, including seizure disorders, severe headaches, depression, and chronic pain, and they are in development for many others including blood pressure, arthritis, diabetes, Parkinson’s disease, and some forms of blindness and dementia.
Many of the available methods rely on implantable devices placed in the upper chest that transmit mild electrical pulses via an electrode to the vagus nerve. An example is LivaNova’s Symmetry system, aimed at relieving the symptoms of treatment-resistant depression. Multiple clinical trials have shown that two-thirds of patients using the Symmetry device experience significant improvements in symptoms, with nearly half of those treated either fully or almost fully recovering from their major depression. While the Symmetry system was approved for use by the FDA in 2019, to date few insurers cover it. Now, LivaNova has partnered with Verily in a study focused on generating real-world evidence to further establish Symmetry’s value and drive insurance coverage. Approximately 300 patients who have failed four or more lines of treatment for a long-lasting or recurrent depression are using Verily’s health-tracking smart watch to measure pulse rate, activity levels, sleep quality, and other health parameters. The data will be used to generate evidence of the impact of the Symmetry system on patients’ overall well-being and their depression.
Handheld bioelectric devices for nerve stimulation are emerging too. U.S. and European regulatory authorities have granted clearance to ElectroCore for their GammaCore vagus nerve stimulation device to treat and prevent cluster headaches and migraines. The company received an Emergency Use Authorization from the FDA in 2020 for use of the device to relieve asthma symptoms in patients with COVID-19. The GammaCore device works by transmitting a light electrical pulse to the vagus nerve via a conductive gel applied to the skin of the patient’s neck. In July, researchers published the results of a study aimed at showing the ability of the GammaCore device to combat fatigue and improve cognition and wakefulness in active-duty soldiers working all-night shifts. Half the study participants used GammaCore for eight minutes at the start of their shift, while another half used a sham device that did not produce an electrical current. Those using the GammaCore device showed, over the study period, a lower decline in performing perception-related tasks, such as taking in and synthesizing audio or visual information, as well as less overall fatigue. Another recently published study of the GammaCore device has shown its ability to improve walking and motor abilities and to ease gait freezing in adults with Parkinson’s disease.
In the area of chronic pain, Neuralace received FDA clearance in June for its noninvasive Axon Therapy System for the relief of pain following surgeries, limb loss, severe burns, car accidents, and other traumatic injuries. Neuralace’s device differs from other neuromodulation devices as it acts at the level of peripheral nerves, not the CNS, where the body’s natural pain modulating mechanisms have become damaged or dormant because of the injury, resulting in chronic pain. When placed over areas of nerve damage, Neuralace’s device emits subtle magnet pulses through the skin that stimulate the malfunctioning nerve cells, thereby reducing the pain. Treatment with the device takes less than 15 minutes, and patients in multiple small-size studies have reported up to 36% pain reduction after a single treatment session. Now Neuralace has begun a randomized controlled study in 126 patients with post-traumatic peripheral neuropathic pain, where treatment with Axon Therapy will be compared to conventional pain management approaches.