NorthStar Neuroscience and translational science in post-motor stroke neurostimulation

An Overview of the history of Northstar Neuroscience, Inc.

 Northstar Neuroscience Inc. was an American company that was centered on the development and marketing of various neuromodulation therapies targeted to improve the quality of life of individuals suffering from a wide group of neurological disorders. The company was founded in 1999 and was initially named Vertis Neuroscience, Inc. which had been changed to Northstar Neuroscience, Inc. in 2003.

Renova – ST

Renova-ST was the company’s primary product which was a cerebral cortex neurostimulation system that was used to deliver targeted stimulatory current to the cerebral cortex. Since early 2000, the company had been conducting a group of clinical trials that examined the safety and efficacy of Renova-ST in the management of various neurological disorders such as stroke, tinnitus, stroke induced aphasia and major depression.

The Renova-ST consisted of a neurostimulator device, cortical stimulation electrodes and a special programming system.

-         Neurostimulator: which is an electrical stimulating device that is usually implanted under the skin of the upper chest area.

-         Cortical stimulation electrodes: which are leads connected to the neurostimulator device. They are placed over the cerebral cortex to deliver stimulating electric current to the target area of the cortex.

-         Programming system: which is a form of a portable computer that permits communication with the implanted neurostimulating device. It allows the physician to modify the parameters of cortical stimulation.

The Everest Trial

Northstar Neuroscience conducted a major clinical trial, which was known as the Everest trial, which examined the efficacy of the Renova neurostimulation system in association with special rehabilitation therapies in recovery of arm functions in upper limb hemiparesis caused by stroke. Unfortunately, as of January 2008, Northstar Neuroscience announced that the Everest trial had failed to meet its predefined main end point.

The trial’s end point was a form of a composite that was utilized to assess the gains in the functions of hand and arm after 4 weeks of completion of rehabilitation therapy as measured by the Upper Extremity Fugl-Meyer test (UEFM). The assessment also included the patients’ ability to perform normal daily activities via the Arm Motor Ability test (AMAT).

The winding down of Northstar Neuroscience, Inc.

In January 2008, John Bowers, the CEO of Northstar Neuroscience, Inc., announced that the Everest trial failed to support positive effects of cortical neurostimulation therapy on the recovery of motor stroke which was proven in past studies.  However, there has been much debate into the causes of the failure…subsequent analysis of the data has shown that if the surgical implant was done with imaging (business types cut this cost out of the pivotal study), then the results were extraordinary…by the time this was shown, the investors had taken nearly $90M dollars out of the company, wound it down and sold the IP to Advanced Neuromodulation–St. Jude.   St. Jude has not done anything in this space and recently reported a large layoff in their deep brain stimulation unit.