First In-Human Experience With Complete Integration of Neuromodulation Device Within a Customized Cranial Implant

Chad R Gordon; Gabriel F Santiago; Judy Huang; Gregory K Bergey; Shuya Liu; Mehran Armand; Henry Brem; William S Anderson

doi:10.1093/ons/opx210

First In-Human Experience With Complete Integration of Neuromodulation Device Within a Customized Cranial Implant

Oper Neurosurg (Hagerstown). 2018 Jul 1;15(1):39-45. doi: 10.1093/ons/opx210.

Authors

Chad R Gordon^{1

2}, Gabriel F Santiago^{1

2}, Judy Huang², Gregory K Bergey³, Shuya Liu⁴, Mehran Armand^{4

5}, Henry Brem², William S Anderson²

Affiliations

¹ Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, The Johns Hopkins Hospital, Baltimore Maryland.
² Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
³ Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
⁴ Department of Mechanical Engineering, Johns Hopkins University, Baltimore, Maryland.
⁵ Johns Hopkins University Applied Physics Laboratory, Laurel, Maryland.

PMID: 29029236
DOI: 10.1093/ons/opx210

Abstract

Background: Neuromodulation devices have the potential to transform modern day treatments for patients with medicine-resistant neurological disease. For instance, the NeuroPace System (NeuroPace Inc, Mountain View, California) is a Food and Drug Administration (FDA)-approved device developed for closed-loop direct brain neurostimulation in the setting of drug-resistant focal epilepsy. However, current methods require placement either above or below the skull in nonanatomic locations. This type of positioning has several drawbacks including visible deformities and scalp pressure from underneath leading to eventual wound healing difficulties, micromotion of hardware with infection, and extrusion leading to premature explantation.

Objective: To introduce complete integration of a neuromodulation device within a customized cranial implant for biocompatibility optimization and prevention of visible deformity.

Methods: We report a patient with drug-resistant focal epilepsy despite previous seizure surgery and maximized medical therapy. Preoperative imaging demonstrated severe resorption of previous bone flap causing deformity and risk for injury. She underwent successful responsive neurostimulation device implantation via complete integration within a clear customized cranial implant.

Results: The patient has recovered well without complication and has been followed closely for 180 d. Device interrogation with electrocorticographic data transmission has been successfully performed through the clear implant material for the first time with no evidence of any wireless transmission interference.

Conclusion: Cranial contour irregularities, implant site infection, and bone flap resorption/osteomyelitis are adverse events associated with implantable neurotechnology. This method represents a novel strategy to incorporate all future neuromodulation devices within the confines of a low-profile, computer-designed cranial implant and the newfound potential to eliminate contour irregularities, improve outcomes, and optimize patient satisfaction.

Publication types

Case Reports

MeSH terms

Brain / surgery*
Deep Brain Stimulation*
Drug Resistant Epilepsy / surgery*
Epilepsies, Partial / surgery*
Female
Humans
Implantable Neurostimulators*
Middle Aged
Treatment Outcome