BOSTON--(BUSINESS WIRE)--Highland Instruments, Inc., (“Highland”) today announced the award for a Fast Track SBIR Grant from the National Center for Complementary and Integrative Health ("NCCIH") for the clinical evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) technology for noninvasive brain stimulation for pain suppression in patients with Osteoarthritis of the Knee ("OA")1. The main academic partner collaborator in this grant and location of the clinical trial will be Spaulding Rehabilitation (“Spaulding”) Hospital’s Laboratory of Neuromodulation (Boston). Felipe Fregni, MD, PhD, MPH, will be the Lead Clinical Investigator. Dr. Fregni is the Director of the Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital and Associate Professor of PM&R and Neurology at Harvard Medical School.
Bill Edelman, Chairman of the Board for Highland, commented, “We are thrilled to have received a new NIH award for the clinical evaluation of ESStim in OA patients. The award is the fourth NIH award directed at the evaluation of ESStim. We have seen positive clinical results for non-invasive ESStim treatments in patients with Parkinson's Disease ("PD") as well as OA patients. We look forward to further expanding the clinical capabilities of this technology in OA through this award. Dr. Fregni is a pioneer in the field of noninvasive brain stimulation, having conducted groundbreaking trials exploring neuromodulation treatments for chronic pain, Parkinson's disease, and stroke.”
Timothy Wagner, PhD, Chief Scientific Officer and Founder for Highland commented, “I am excited to see ESStim in the clinic.” Dr. Wagner continued, “We hope that ESStim will overcome limitations of other reported non-invasive brain stimulation technologies.”
Dr. Felipe Fregni commented, "Receiving this highly competitive grant is encouraging for the development of this novel method of stimulation as we continue to investigate the clinical utility of ESStim as a possible therapy for OA. Our preliminary analysis in a series of 18 patients with OA of the knee undergoing ESStim treatment demonstrated statistically significant improvement in key clinical measurements employed to manage OA patients. Specifically, we assessed pain via a Visual Analog Scale ("VAS") following fixed doses of ESStim for 5 days, 20 minutes/day. VAS scores were taken at the end of the stimulation visits and at two, four, and six weeks post stimulation. Patients that received Active ESStim showed significant effects lasting up to four weeks post stimulation. A 2-way ANOVA of the VAS scores was significant for visit number (p<0.05) and stimulation type (p <0.001). In a separate series of 20 PD patients undergoing ESStim treatment, we demonstrated statistically significant improvement in key clinical measurements employed to manage PD patients. Our results showed that patients undergoing ESStim™ treatment experienced significant improvements relative to baseline measurements when compared to SHAM stimulation for the following clinical measurements: (1) Walking times improved (p<0.01), (2) Unified Parkinson's Disease Rating Scale ("UPDRS") improved (p=0.058), (3) UPDRS Part III related to bradykinesia and rigidity improved (p<0.05), (4) Bradykinesia test times improved (p<0.01). We also demonstrated that significant effects lasted up to 4 weeks post stimulation. Furthermore, safety data monitored following ESStim™ treatment demonstrated no neurocognitive decline, no seizure activity on EEG, and no new neurological signs or symptoms.”
Dr. Fregni continued, “The additional award of this NIH grant will be important to advance our knowledge of noninvasive brain stimulation and we are glad that our Neuromodulation Center at Spaulding Rehabilitation Hospital is a critical component of this investigation. We look forward to further clinical evaluation of ESStim in this collaborative grant."
Highland previously reported on December 2, 2013, presentation of "Electrosonic Stimulation As Adjunctive Therapy To Dopaminergic Treatments In Parkinson's Disease", during the 5th International Symposium on Neuromodulation, held September 16-18, 2013 at Mackenzie Presbyterian University, Sao Paulo, Brazil.
Highland previously reported on November 18, 2013, presentation of “Effects of Electrosonic Stimulation on the Perception of Chronic Pain Due to Osteoarthritis of the Knee”, during the 5th International Symposium on Neuromodulation, held September 16-18, 2013 at Mackenzie Presbyterian University, São Paulo, Brazil.
Highland previously reported on October 23, 2013, Institutional Review Board (“IRB”) Approval to initiate clinical evaluation of non-invasive brain stimulation technologies in patients with Parkinson’s Disease.
Highland previously reported on July 30, 2013, award of Small Business Innovation Research (“SBIR”) Grant for clinical evaluation of non-invasive brain stimulation technologies.
During October 2011, Highland initiated a clinical evaluation of ESStim in patients with chronic pain due to osteoarthritis.
On December 16, 2010, Highland received Institutional Review Board (“IRB”) approval at Spaulding Rehabilitation Hospital to initiate clinical evaluation ESStim for the management of chronic pain due to osteoarthritis.
About Osteoarthritis of the Knee
Osteoarthritis (OA) is the most common form of knee arthritis. OA is usually a slowly progressive degenerative disease in which the joint cartilage gradually wears away. It most often affects middle-aged and older people2. OA is the most common form of arthritis, affecting nearly 27 million Americans or 12.1% of the adult population of the United States3. In the U.S. alone, more than 10 million people are estimated to have OA in one or both knees4. The combined annual costs of knee and hip arthroplasty in 2007 are estimated to have been approximately $15.6 billion based on data compiled by the Healthcare Costs and Utilization Project (HCUP)5.
About Parkinson's Disease
Parkinson's Disease ("PD") is a progressive and ultimately fatal neurodegenerative disease characterized by debilitating physical symptoms including resting tremor, rigidity, bradykinesia, and gait dysfunction6,7. Approximately 50,000-100,000 Americans are diagnosed with PD each year, with over 1 million Americans affected at any given time. PD is a disease of late middle age, usually affecting people over the age of 50. Recently, some healthcare providers have reported increasing cases of "early-onset" Parkinson's disease in the past several years, and some have estimated that 5 to 10 percent of those sufferers are under the age of 408. Parkinson's disease was listed by the National Center for Health Statistics ("NCHS") as one of the top 15 causes of death during 2007. In 2007, there were 20,000 Parkinson's-related fatalities in the US9. It is estimated that the annual costs of Parkinson's disease exceeds $25 billion10.
About ElectroSonic Stimulation (“ESStim™”) Technology
Electrosonic Stimulation11 (ESStim™) is an innovative noninvasive neurostimulation technology. ESStim combines independently controlled electromagnetic and ultrasonic fields. The combined fields focus and boost neurostimulation currents via tuned electromechanical coupling in neural tissue. ESStim clinical studies in patients with PD and OA have demonstrated a significantly improved duration and magnitude of stimulation effect compared to controls in treating the morbidities associated with the respective diseases.
About Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital is affiliated with Harvard Medical School, the Massachusetts General Hospital Institute of Health Professionals, and Partners Health Care System, an integrated health care delivery system that includes Massachusetts General Hospital and Brigham and Women’s Hospital. SRH is one of the largest rehabilitation facilities in the U.S. and is a leader in the greater Boston metropolitan area in providing comprehensive rehabilitation and complex medical management services. It is the only rehabilitation hospital in New England to maintain a ranking in the top 10 in U.S. News and World Report’s Best Hospitals survey since 1995; this year it was ranked number 6.
The Harvard Medical School Department of Physical Medicine and Rehabilitation is based at Spaulding. Spaulding is one of the largest rehabilitation hospitals of its kind in the United States, with 296 beds, more than 3000 inpatient admissions per year and a large outpatient service. The main campus also offers more than 15 specialty rehabilitation programs with representatives from 30 medical specialties, including Cardiology, Pulmonology, and Rheumatology to name a few. For this particular study, Spaulding Rehabilitation Hospital is home to the Neurology Rehabilitation Program. The staff in this department will assist with recruitment and care and follow-up with Parkinson’s disease patients. The Neurology Rehabilitation Program at Spaulding Rehabilitation Hospital specializes in a variety of inpatient and outpatient services, including daily medical management, education, and support for Parkinson’s patients and their families. The team works with each patient towards individual goals.
About Highland Instruments, Inc.
Highland Instruments is a privately held medical device company pioneering the development and commercialization of ESStim™, an innovative noninvasive electrosonic brain stimulation technology for the treatment of brain-based movement disorders as well as chronic pain management. Highland Instruments was founded in 2007 by researchers trained at Harvard Medical School and MIT. Highland is developing ESStim technology to treat osteoarthritis patients suffering from chronic pain as well patients with brain-based movement disorders.
1 Research reported in this publication is to be 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.
3 Arthritis Rheum. 2008;58(1):26-35.
5 Agency for Healthcare Research and Quality Web site. http://hcupnet.ahrq.gov/HCUPnet.jsp
6 American Journal of Epidemiology, 2003. 157(11): p. 1015-22
7 Annual Review of Neuroscience, 2006
9 American Journal of Epidemiology, 2003. 157(11): p. 1015-22
10 Movement Disorders, 2005 Nov;20(11):1449-54
11 Patents Issued and Pending