Next Generation Parkinson's Disease Treatment through Steering Brain Stimulation (NEXT)

Objective/Rationale:
Deep Brain Stimulation (DBS) can provide a radical improvement in the quality of life of Parkinson’s patients. However, it is a complex procedure with a large incidence of complications and side-effects. NEXT enables Steering Brain Stimulation (SBS) by delivering stimulation exclusively to the intended functionally therapeutic brain structures, which will both improve therapeutic outcome and drastically reduce stimulation-induced side effects for Parkinson’s patients.
Project Description:
DBS implants require both an implantable pulse generator (IPG) and a lead that delivers the electrical stimulation. Steering Brain Stimulation (SBS) achieves advanced local stimulation through a large number of electrodes that have a higher resolution than the leads currently available for DBS. A specific requirement is that the IPG should be replaceable which in the case of SBS means that a hermetic and biocompatible connector should be realized that reliably connects a large number of electrical wires. This advanced connector is developed within NEXT which is made possible through the support of the Michael J. Fox Foundation and can be considered to be a premiere for active implants in general and Parkinson’s Disease treatment in particular.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
By enabling the accurate delivery of the electric stimulation to a specific brain region – often the SubThalamic Nucleus (STN) – SBS holds the promise of spectacular impact on DBS patients with Parkinson’s disease: strongly improved motor skills, large reduction of levodopa doses, with levodopa-induced dyskinesias and disability reducing accordingly and improved sleep duration and quality. The NEXT project is key to the realization of the very first SBS implants of Sapiens Steering Brain Stimulation B.V. (Sapiens).
Anticipated Outcome:
NEXT is aimed at producing a hermetic and biocompatible advanced connector which is a key challenge in the SBS implant design. We will develop and demonstrate the connection of an unprecedented number of electric wires on a miniaturized surface. Prototypes will be produced and the design validated with assessments on all key aspects including hermeticity and reliability. After the successful completion of NEXT, Sapiens will start clinical validation studies of its Steering Brain Stimulation therapy.