CranialProgrammer: Image-Guided Directional Deep Brain Stimulation Programming Using Local-Field Potentials

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1U44NS108148-01
Agency Tracking Number: U44NS108148
Amount: $838,241.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 105
Solicitation Number: NS17-007
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-30
Award End Date (Contract End Date): 2019-09-29
Small Business Information
77 CALLE ARRECIPE, Dorado, PR, 00646-2040
DUNS: 080396742
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (919) 614-8833
Business Contact
Phone: (469) 222-2350
Research Institution
ABSTRACT The goal of this Uproposal is to develop and test CranialProgrammeran image guided programming tool forDD mapping of disease related neural signals over patient and device data for more efficient and effective programming of directional deep brain stimulationDBSsystemsDBS is an established treatment for advancedrefractory movement disorders used in overpatientsHowevermany patients receive inadequate symptom control due to poorly placed DBS leadscurrent spread to unwanted structuresor nonoptimized stimulation parametersall of which are caused or exacerbated by the use of conventionalcontactomnidirectionalleadsRecent advances show directional leadsi econtact leads with circumferentially segmented electrodes in aconfigurationcan alleviate limitations by steering current toward pathological regions of interestROIsand away from unwanted structuresThis can increase DBS efficacy and widen therapeutic windowsTWup toHoweverthe greater numbers of contacts on directional leads adds more possible monopolar and bipolar configurationsespecially when combined with independent current sources that distribute current unevenly across contactsAlthough these advancements offer unprecedented therapeutic controlthe time needed to explore all possible parameters is overwhelmingTools are needed to narrow the neurologistandapos s focus for identification of correct programming settings on directional DBS leadsRecent studies show features of basal ganglia local field potentialsLFPsare strongly correlated to Parkinsonandapos s diseasePDsymptomsindicating LFPs can be used to guide DBS toward the pathological ROIThereforea new programming method using LFP maps could harness directional lead benefits by offsetting their added complexityTo this endwe propose CranialProgrammeran intuitiveLFPbased DBS programming software module to facilitate contact selection on directional leadsIt will interface with Nexeonandapos s SynapseTM DBS Systemwhich has unprecedented capabilities for directional stimulation and directional LFP sensing in DBS implantsCranialProgrammer will allow visualization of disease related LFPs collected by the Synapse and mapped over multimodal patient dataincluding brain MRICT images of lead implantsmicroelectrode recordingsand motor scoresIt will provide clinicians with auto generatedeasilynavigabledata rich patient images to select the best contact for directional DBS more efficiently and effectivelyIn Phase I we will automate CranialProgrammer to perform data entryanalysis and spatial mapping of LFPs on multi modal datasets via the Nexeon External Research SystemERSAimWe will perform verification and validation testingAimand get IRB approval for a clinical studyAimIn Phase II we will validate efficacy of map based selection compared to clinical selection on PD patientsNwith the chronically implanted Synapse deviceThe Criteria for Success isof patients exhibit either a clinically meaningful increase in therapeutic windowandgtor efficacyandgtpt in UPDRS IIIwhen programmed with CranialProgrammer PROJECT NARRATIVE Deep brain stimulationDBSis an established treatment for advanced Parkinson s diseasebut many patients receive inadequate symptom controlCurrent steering with directional leads has shown great potential to improve DBS efficacy by targeting diseased brain regions and avoiding off target effectshowevercurrent steering widens the parameter spaceadding significant complexity to post operative DBS programmingWe propose the development of CranialProgrammeran intuitiveimage guided tool forDD mapping of disease related neural signals over patient and device data for more efficient and effective programming of directional leads

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