Spaulding Rehabilitation Hospital at Harvard Medical School and Highland Instruments, Inc., Jointly Announce National Institutes of Health Funded Clinical Trial Investigating Highland's Electrosonic Stimulation Technology to Treat Postural Instability in Parkinson's Disease

BOSTON, Dec. 7, 2021 /PRNewswire/ -- Spaulding Rehabilitation Hospital at Harvard Medical School and Highland Instruments, Inc., ("Highland") today jointly announced the launch of a National Institutes of Health ("NIH") funded Clinical Trial investigating Highland Instruments' Electrosonic Stimulation ("ESStim™"), a novel noninvasive brain stimulation technology, to treat Postural Instability in Parkinson's Disease ("PD")¹. The double-blinded randomized controlled trial ("RCT") is an NIH Small Business Innovative Research ("SBIR") Phase II grant funded study that follows the successful results of Highland's recent NIH funded Phase I SBIR JANUS 3A RCT. In the JANUS 3A RCT, PD patients with balance and gait deficits underwent a course of Highland's ESStim™ therapy in combination with Physical Therapy ("PT"). ESStim™ treated patients demonstrated clinically and statistically significant improvements in Unified Parkinson's Disease Rating Scale assessments with concurrent improvements in objective kinematic metrics descriptive of gait and postural control compared to patients who received PT adjunct to SHAM stimulation. Patients' Quality-of-Life ("QOL") self-assessments also significantly improved, with notable improvements in functional mobility, activities of daily living, and emotional domains. The Phase II SBIR RCT will build upon the results of the Phase I SBIR RCT, investigating a larger patient pool, extending the period of treatment and observation, and examining balance and gait endpoints not classically improved with other currently available pharmaceutical and stimulation therapies for PD.

Professor Felipe Fregni, MD, PhD, MMSc, MPH, MEd, (Spaulding Rehabilitation Hospital trial site Principal Investigator, Harvard Medical School) stated "Results from the first phase of the study demonstrated Parkinson's Disease patient improvement in gait and postural impairments which are known to be among the greatest factors affecting quality of life in Parkinson's Disease patients. Parkinson's Disease patients with postural instability have limited treatment options and thus the ESStim™ combined with PT approach could be quite impactful in these patients. The second phase of the study will expand the patient pool, provide therapy for an extended period, and gather data which could optimize ESStim™ therapies for patients with postural instability. We are excited to have patients now underway in the Phase II study."

About Parkinson's Disease (PD)
Nearly one million people in the U.S. are living with PD. The combined direct and indirect cost of PD, including treatment, social security payments and lost income, is estimated to be nearly $52 billion per year in the U.S. alone². In patients with PD, postural instability is a leading cause of disability, dependence on others, and mortality. Current treatments for PD, including pharmacological and surgical methods, have limited impact on postural instability.

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. Highland is pioneering the development of ESStim™³, an innovative noninvasive brain stimulation technology to treat Parkinson's Disease. ESStim™ has also been successfully implemented for the treatment of chronic pain (including osteoarthritis, lower back pain, and diabetic neuropathic pain) and is being investigated for the treatment of Opioid Use Disorder. Highland previously received 510(k) 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, MA. 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 Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R44NS110237. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

² https://www.parkinson.org/Understanding-Parkinsons/Statistics

³ Electrosonic Stimulation is protected by patents, both issued and pending.

SOURCE Highland Instruments, Inc.

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