Spaulding Rehabilitation Hospital at Harvard Medical School and Highland Instruments, Inc., (“Highland”) jointly today announced clinical results of a NIH1 Sponsored Phase II Clinical Trial investigating Highland Instruments’ novel noninvasive neuromodulation technology Electrosonic Stimulation2 (“ESStim™”) to treat Chronic Osteoarthritis Knee Pain3 (ALGEA 2).
The double-blinded randomized controlled trial studied 64 patients that underwent a course of Highland’s ESStim™ therapy, given 20 minutes/day over 10 days and were assessed up to 8 weeks post therapy. Study end-points were successfully achieved, with clinically and statistically significant improvements in patient pain reduction, reduced drug use, and improved biomechanics. At 1 month post ESStim™ therapy, patient Visual Analogue Scale (VAS) pain scores were reduced by ~53% (Active) vs ~22 % (SHAM) (p<0.05). Additionally, Active ESStim™ therapy patients consumed approximately 1/3 of pain medications vs. SHAM patients through the trial (assessed as Acetaminophen Equivalent use per day).
Spaulding Principal Investigator, Felipe Fregni, MD, PhD, MMSc, MPH, MEd, stated “We have seen great results with ESStim™ across the chronic pain and movement disorder indications. While the data speaks for itself, such as the sustained reduced pain in the chronic pain patients and improved mobility in the Parkinson’s patients, a noninvasive approach which can improve patient’s quality of life without the side-effects of drugs is very exciting.”
Dr. Felipe Fregni is the Director of the Spaulding Neuromodulation Center. He has an M.D. and Ph.D. from University of Sao Paulo, M.M.Sc. Scholars in Clinical Science Program at Harvard Medical School and M.P.H. Clinical Effectiveness at Harvard School of Public Health and a Masters of Education (M.Ed.) from Harvard Graduate School of Education. He completed his Neurology Residency at University of Sao Paulo, post-doctoral training in Neuroscience at Beth Israel Deaconess Medical Center in Boston and was a visiting fellow in Neurophysiology at Federal University of Pernambuco as well as in Clinical Neurophysiology at University of Goettingen, Germany. He is a Professor of Physical Medicine and Rehabilitation at Harvard Medical School and a Professor in the Department of Epidemiology Harvard T.H. Chan School of Public Health.
Electrosonic Stimulation (“ESStim™”), an innovative noninvasive electrosonic brain stimulation technology to treat chronic pain (from osteoarthritis, lower back pain, diabetic neuropathic pain, carpal tunnel syndrome pain). ESStim™ has also been successfully implemented in the Parkinson’s disease population and is currently being explored to treat Opioid Use Disorder. Highland previously received 510(k)[4] premarket clearance for the ESStim™ 001, which implements ESStim™ technology.
Other clinical trials in the news.