Spaulding Rehabilitation Hospital at Harvard Medical School and Highland Instruments Inc announce the launch of a National Institutes of Health-funded Clinical Trial investigating Highland Instruments’ Electrosonic Stimulation, a novel noninvasive brain stimulation technology, to treat Postural Instability in Parkinson’s Disease.

The double-blinded randomized controlled trial is an NIH Small Business Innovative Research 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.

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 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.

“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.”

— Professor Felipe Fregni, MD, PhD, MMSc, MPH, MEd, (Spaulding Rehabilitation Hospital trial site Principal Investigator, Harvard Medical School)

[Source(s): Highland Instruments Inc, PR Newswire]