Spaulding Rehabilitation Hospital at Harvard Medical School and Highland Instruments, Inc., Jointly Announce Release of ALGEA 2 Clinical Trial Results Investigating Highland's Electrosonic Stimulation ("ESStim™") Technology to Treat Chronic Osteoarthritis Knee Pain

BOSTON, Nov. 8, 2021 /PRNewswire/ -- 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."

About Felipe Fregni, MD, PhD, MMSc, MPH, Med
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.

About Highland Instruments, Inc. and ESStim™ Technology
Highland Instruments is a privately held medical device company, founded in 2007 by researchers trained at Harvard Medical School and MIT, pioneering the development and commercialization of 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.

About Spaulding Rehabilitation Hospital
The Spaulding Rehabilitation Hospital is a 132-bed rehabilitation teaching hospital located in Boston, Massachusetts. It is the official teaching hospital for Harvard Medical School's Department of Physical Medicine and Rehabilitation and the main campus of the Spaulding Rehabilitation Network.  The hospital is a member of Mass General Brigham health system.

Spaulding Rehabilitation Hospital has been the only hospital in New England to be continuously ranked by the U.S. News and World Report in its "Best Hospitals Survey" since 1995.

Contact:
Bill Edelman, CEO
[email protected]
(781) 436-0509

Tim Wagner, PhD, CSO
[email protected]
(617) 504-6031

¹ Research reported in this publication was supported by the National Center for Complementary & Integrative Health of the National Institutes of Health under Award Number R44AT008637. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

² Electrosonic Stimulation is protected by patents, both issued and pending.

³ https://clinicaltrials.gov/ct2/show/results/NCT02723929

⁴ Highland Instruments, Inc. received FDA 510(k) premarket clearance June 2011.

SOURCE Highland Instruments, Inc.