The Feinstein Institute for Medical Research has reported positive results from a pilot clinical trial conducted to assess the use of a bioelectronic medicinal device for alleviating pain and fatigue in lupus patients.
Developed by a research team at the Center for Bioelectronic Medicine at the Feinstein Institute, the bioelectronic lupus device delivers vagus nerve stimulation.
Lupus is a chronic autoimmune disease characterised by inflammation and musculoskeletal pain. Commonly, immune-suppressing drugs are used to reduce the disease flare-ups and inflammation.
However, such medicines are said to be not effective in all types of lupus patients and can result in side effects.
The Feinstein Institute clinical trial investigated the safety and efficacy of external vagus nerve stimulation with the new device. Data showed that the approach significantly minimised pain and fatigue in the patients.
For the trial design, the team used its previous observations from the stimulation of the vagus nerve and immune system in patients suffering from rheumatoid arthritis.
Center for Bioelectronic Medicine Bioelectronics and Biosensing Lab assistant professor Dr Timir Datta-Chaudhuri said: “Many bioelectronic medicine devices are surgically implanted, and we wanted to see if an external device would be as effective, providing patients with an alternative to surgery.
“The initial results here suggest that our device has the potential to help patients. Further studies are needed to confirm this result.”
The results will be presented at the American College of Rheumatology/Association of Rheumatology Professional’s (ACR/ARHP) annual meeting.
This biodegradable implant has been designed to accelerate nerve regeneration and improve the healing of a damaged nerve.