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.
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).
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.
The most challenging aspect of the advanced connector design relates to the many electronic connections that need to be made in a compact form factor. A novel approach has been taken in the project that allows for realizing the connector based on commercially available interconnection technology in combination with an intermediate material that completes the interconnect system. The feasibility of the concept has been proven for arrays of 16 pins in initial prototypes, a number sufficiently high to capture the essential challenges of this key miniaturization activity. This feasibility phase establishes the basis for the design of the fully functional high-pin-count design that can be released for human clinical devices.
This grant was selected by The Michael J. Fox Foundation staff to be highlighted via the Foundation’s Partnering Program.