Spaulding Rehabilitation Hospital and Highland Instruments, Inc., Jointly Announce Use of Integrated Motion Analysis Suite as Part of a NIH Funded Parkinson's Disease Trial

BOSTON, Nov. 17, 2022 /PRNewswire/ -- Spaulding Rehabilitation Hospital, a teaching affiliate of Harvard Medical School, and Highland Instruments, Inc., ("Highland") today jointly announced the planned use of second generation Integrated Motion Analysis Suite ("IMAS") as part of a National Institutes of Health ("NIH") funded Clinical Trial investigating Highland Instruments' Electrosonic Stimulation ("ESStim^™"), a novel noninvasive brain stimulation technology, for 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. While PD diagnoses and ongoing motor assessments by Movement Disorder specialists can be quite accurate, non-specialists make errors upwards of 25% of the time^2,3. The IMAS has been designed to objectively assess patient kinematics during motor exams with less variability than made during typical motor exams. The IMAS system is being used to improve objective motor assessments in PD undergoing ESStim^™ therapy. Ultimately, the IMAS system is also being explored as a tool to optimize patient therapy, such as the delivery of neurostimulation dose.

Laura Dipietro, PhD (Highland Instruments), one of the developers of the IMAS system stated, "We are excited to advance our IMAS system into the clinic and look forward to implementing it not just in PD, but throughout the fields of neurology, rehabilitation, and physical medicine where assessing patient movement is critical to care."

Felipe Fregni, MD, PhD, MMSc, MPH, MEd, (Spaulding Rehabilitation Hospital trial site Principal Investigator, Professor, Harvard Medical School) stated, "In this JANUS series of trials, ESStim^™ treated patients demonstrated clinically and statistically significant improvements in Unified Parkinson's Disease Rating Scale assessments and numerous other clinical endpoints. Objective kinematic assessments are key for understanding the impact of therapy in these patients and delivering optimal care. The IMAS system will not only continue to aid us in the JANUS trials, it offers a potential future tool that can aid care givers in the diagnosis and management of movement disorders."

IMAS is also currently being investigated as a tool to predict stroke recovery in acute stroke patients.

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. alone⁴. 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.

Highland Instruments is a privately held medical device company, founded by researchers trained at Harvard Medical School and MIT. Highland is pioneering the development of ESStim^™5, 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.

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:
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 and R43NS113737. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
² http://www.ncbi.nlm.nih.gov/pubmed/10714663
³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204150/
⁴ https://www.parkinson.org/Understanding-Parkinsons/Statistics
⁵ Electrosonic Stimulation is protected by patents, both issued and pending.

SOURCE HIGHLAND INSTRUMENTS INC