Highland Instruments Announces Positive ESStim™ Clinical Study Results for Parkinson's Disease

CAMBRIDGE, Mass. - Sept. 24, 2025 - PRLog -- Highland Instruments announced positive results of a clinical trial investigating ESStim™, Highland's novel noninvasive brain stimulation platform, to treat Parkinson's Disease (PD) symptoms.

The Phase II trial enrolled 40 participants with PD, who were randomized to receive either active ESStim™ or sham stimulation combined with physical therapy (PT). Patients received ten 20-minute stimulation treatment sessions over two weeks, plus an additional two weeks of biweekly stimulation with PT. Patients were evaluated over an 8-week follow-up period. All participants were treated during the "on" phase of their PD medications.

The study successfully met its end points, with patients receiving ESStim™ treatment demonstrating clinically and statistically significant improvements in motor symptoms when compared to both baseline and sham stimulation as measured by Unified Parkinson's Disease Rating Scale Part III (UPDRS-III). On average, ESStim™ patients demonstrated a 5.7-point improvement in UPDRS-III scores from baseline during medication 'on' periods (mean baseline score: 15.3) at the 8-week post-treatment assessment point. The improvement in motor symptoms from the combination of ESStim™ treatment and PT can potentially empower PD patients to resume daily activities and gain increased independence.

Felipe Fregni, MD, PhD, MMSc, MPH, Med, Director of the Spaulding Neuromodulation Center at Spaulding Rehabilitation Hospital served as the Principal Investigator and Spaulding Rehabilitation Hospital served as a lead site for the study. The study was supported by a grant from National Institutes of Health's (NIH) National Institute of Neurological Disorders and Stroke (NINDS).

Dr. Tim Wagner, founder and CSO of Highland stated "we are very encouraged by the results of JANUS 3B, which demonstrate ESStim™'s potential to empower patients to address Parkinson's Disease symptoms. We look forward to the future pivotal study and eventual commercialization of ESStim™."

"We are excited by the strong clinical results from ESStim™ treatment," added Dr. Laura Dipietro, Highland's CTO. "By improving PD patients' motor symptoms, particularly those related to balance, posture, slowness of movement, and walking, ESStim™ can potentially help PD patients improve their quality of life."

About Highland Instruments, Inc. and ESStim™ Technology
Highland Instruments is developing ESStim™ - a novel noninvasive brain stimulation platform to help patients address movement disorders. Learn more at www.highlandinstruments.com (https://www.highlandinstruments.us/).

ESStim™ has not been approved by the Food and Drug Administration for a specific clinical indication. This technology is not in commercial distribution in the United States or inter­nationally. Please contact Highland Instruments for additional information regarding this technology and potential clinical application.

Research reported in this publication was supported by NINDS under Award Number R44NS110237. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.