. In the United States, over 100,000 deep brain stimulation (DBS) devices have been implanted to date for treatment of basic tremor, Parkinson?s disease and dystonia, and clinical trials are underway to evaluate indications for chronic pain, severe depression, migraines and dementia. DBS devices belong to a class of devices called implantable electrical stimulators, and close to 1 Million of these devices are implanted annually. While effective in many cases, DBS shows limited effectiveness in others and also has side effects. Preclinical studies predict that DBS arrays comprised of many densely packed, small electrodes can more precisely target specific regions of the brain to improve therapy. Further, incorporating some electrodes which can provide sensory feedback (closed loop) may be able to improve therapy efficiency and effectiveness. These discoveries are motivating the neuromodulation industry to develop smaller, less invasive electrodes. However, current electrode materials do not support small sizes without severely restricting the stimulus output. Hence, an improved electrode material will benefit present and future DBS systems. Platinum Group Coatings LLC has developed a cost-effective and materials-efficient process for applying an ultra-low impedance platinum-iridium alloy coating onto the contacts of DBS stimulator and cortical recording electrodes. This program, in collaboration with University of Minnesota, seeks to validate the performance advantages of this coating when applied to a novel, flex circuit electrode array for DBS. Specifically, PtIr-coated thin film electrodes will be tested in bi-directional (i.e. stimulation and sensing) modalities to assess efficacy as well as material safety and stability in a non-human primate model of Parkinson?s disease. This phase-II research will seek to determine the durability and longevity of Pt-Ir coating on thin-film high-density DBS electrodes used bi-directionally to assess the long-term recording and stimulation performance of the coatings in vivo.

Public Health Relevance

. Deep Brain Stimulators belong to a class of medical devices called implantable electrical stimulators. Close to 35,000 of these devices are implanted annually, worldwide. These devices use electrodes in contact with tissue to deliver electrical pulses to targeted cells for the purpose of eliciting specific therapeutic responses. Improved electrode materials are proposed that will enable a new generation of implant designs with advanced features like closed-loop feedback which will allow less invasive designs, improved efficacy and better patient outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44NS103714-02
Application #
9564232
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Fertig, Stephanie
Project Start
2017-09-15
Project End
2019-06-30
Budget Start
2018-07-01
Budget End
2019-06-30
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Platinum Group Coatings, LLC
Department
Type
DUNS #
078446209
City
Pasadena
State
CA
Country
United States
Zip Code
91107
Zhang, Simeng; Connolly, Allison T; Madden, Lauren R et al. (2018) High-resolution local field potentials measured with deep brain stimulation arrays. J Neural Eng 15:046019