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Establishing the maximum safe stimulation parameters for platinum cochlear implant electrode arrays.

Award Number: R01DC015031
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Establishing the maximum safe stimulation parameters for platinum cochlear implant electrode arrays. - DESCRIPTION (provided by applicant): Cochlear implants stimulate the auditory nerve using stimuli that minimize the release of toxic electrochemical byproducts and damage associated with metabolic stress of the stimulated neurons. However, these guidelines were based on acute stimulation of cortical neurons and thus do not reflect the safe levels of stimulation for us in a cochlear implant. This application will establish safe stimulation limits specifically for cochlear implants using chronic electrical stimulation. The project will use clinical implants and electrode fabrication technology to manufacture customized electrode arrays for this research with carefully defined surfaces as small as 0.05 mm2. We hypothesize that safe stimulation levels will be significantly greater than the present levels defined by acute studies. If this hypothesis is correct the next generation of cochlear implants could include smaller electrodes and new stimulation strategies leading to improved clinical outcomes for cochlear implant users. This project has three specific aims: i) establish the threshold stimulus levels for electrochemical damage using platinum electrodes. In this study stimulus rate and charge per phase will be held constant while charge density will be varied from 100-400 µC/cm2/phase using purpose built electrode arrays. The prime measures used to evaluate the extent of electrochemical damage will be the degree of tissue response in stimulated versus control cochleae, neural survival and evidence of electrode degradation; ii) establish the threshold stimulus parameters giving rise to metabolic damage following chronic electrical stimulation of the auditory nerve. This study will co-vary charge per phase (0.39-0.78 µC/phase; i.e. from "safe" to the "unsafe" levels defined acutely), stimulation rate (250 - 1000 pulses per second) and duty cycle (25 - 100%). These combinations will allow us to examine the effects of each parameter independently. Metabolic damage is expected to specifically target auditory neurons and therefore electrophysiological response properties and neural survival will be the primary measures to establish the extent of damage and to define safe limits in both chronically stimulated versus control cochleae; and iii) establish the interaction between electrochemical and metabolic damage by co-varying charge density, charge per phase, stimulation rate and duty cycle around the safe / unsafe boundaries determined in aims i) and ii). These results will allow us to determine the extent of interaction, if any, between the electrochemical and metabolic damage, again impacting on safe stimulation levels.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2018	UNIVERSITY OF MELBOURNE	GRATTAN ST	PARKVILLE	VIC			AUS	Research Related to Deafness and Communication Disorders	000	4	12/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	UNIVERSITY OF MELBOURNE	GRATTAN ST	PARKVILLE	VIC	3010		AUS	Research Related to Deafness and Communication Disorders	000	4	7/30/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $315,325 )
2018	2018	UNIVERSITY OF MELBOURNE	GRATTAN ST	PARKVILLE	VIC	3052		AUS	Research Related to Deafness and Communication Disorders	000	4	8/3/2018	NON-COMPETING CONTINUATION	$315,325
														Subtotal = $315,325

Issue Date FY: 2017 ( Subtotal = $311,608 )
2017	2017	UNIVERSITY OF MELBOURNE	GRATTAN ST	PARKVILLE	VIC	3052		AUS	Research Related to Deafness and Communication Disorders	000	3	8/24/2017	NON-COMPETING CONTINUATION	$311,608
														Subtotal = $311,608

Issue Date FY: 2016 ( Subtotal = $623,216 )
2016	2016	UNIVERSITY OF MELBOURNE	**	MELBOURNE				AUS	Research Related to Deafness and Communication Disorders	001	2	8/12/2016	NON-COMPETING CONTINUATION	$311,608
2016	2016	UNIVERSITY OF MELBOURNE	**	MELBOURNE				AUS	Research Related to Deafness and Communication Disorders	000	1	11/17/2015	NEW	$311,608
														Subtotal = $623,216

Grand Total All Awards = $1,250,149

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Establishing the maximum safe stimulation parameters for platinum cochlear implant electrode arrays.

Award Number: R01DC015031

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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