First in-human experience with complete integration of neuromodulation devicewithin 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 devicewithin a customized cranial implant

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

17 Scopus citations

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.

Original language	English (US)
Pages (from-to)	39-45
Number of pages	7
Journal	Operative Neurosurgery
Volume	15
Issue number	1
DOIs	https://doi.org/10.1093/ons/opx210
State	Published - Jul 1 2018

Keywords

Craniofacial surgery
Customized cranial implant
Epilepsy
Epilepsy surgery
Functional surgery
Medical device
Neuromodulation
Neurosurgery

ASJC Scopus subject areas

General Medicine

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10.1093/ons/opx210

Cite this

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title = "First in-human experience with complete integration of neuromodulation devicewithin a customized cranial implant",

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.",

keywords = "Craniofacial surgery, Customized cranial implant, Epilepsy, Epilepsy surgery, Functional surgery, Medical device, Neuromodulation, Neurosurgery",

author = "Gordon, {Chad R.} and Santiago, {Gabriel F.} and Judy Huang and Bergey, {Gregory K.} and Shuya Liu and Mehran Armand and Henry Brem and Anderson, {William S.}",

note = "Publisher Copyright: {\textcopyright} 2017 by the Congress of Neurological Surgeons.",

year = "2018",

month = jul,

day = "1",

doi = "10.1093/ons/opx210",

language = "English (US)",

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T1 - First in-human experience with complete integration of neuromodulation devicewithin a customized cranial implant

AU - Gordon, Chad R.

AU - Santiago, Gabriel F.

AU - Huang, Judy

AU - Bergey, Gregory K.

AU - Liu, Shuya

AU - Armand, Mehran

AU - Brem, Henry

AU - Anderson, William S.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - 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.

AB - 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.

KW - Craniofacial surgery

KW - Customized cranial implant

KW - Epilepsy

KW - Epilepsy surgery

KW - Functional surgery

KW - Medical device

KW - Neuromodulation

KW - Neurosurgery

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SN - 2332-4252

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JO - Operative Neurosurgery

JF - Operative Neurosurgery

IS - 1

ER -

First in-human experience with complete integration of neuromodulation devicewithin a customized cranial implant

Abstract

Keywords

ASJC Scopus subject areas

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