Skin Sympathetic Nerve Activity and Cardiac Arrhythmias

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 9R42DA043391-02
Agency Tracking Number: R42DA043391
Amount: $1,472,476.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-07-01
Award End Date (Contract End Date): 2019-06-30
Small Business Information
351 W 10TH ST, Indianapolis, IN, 46202-4118
DUNS: 078393367
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 THOMAS EVERETT
 (317) 274-0957
 theveret@iu.edu
Business Contact
 JOSEPH TREBLEY
Phone: (765) 376-1471
Email: joe@mononbioventures.com
Research Institution
 INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
 980 Indiana Avenue
Lockfield Village, RM 2232
INDIANAPOLIS, IN, 46202-2915
 Nonprofit college or university
Abstract
DESCRIPTION provided by applicant The objective of this Phase II STTR grant application is to continue the R Randamp D efforts initiated in Phase I The long term objective for Arrhythmotech is to develop and market an instrument for the simultaneous recording of sympathetic nerve activity SNA and electrocardiogram ECG using electrodes on the skin This method neuECG was discovered in Dr Chenandapos s research laboratory at the Krannert Institute of Cardiology and a patent application has been filed by Indiana University Arrhythmotech LLC was founded to further advance this concept and we propose that neuECG will have significant commercial value by providing a new tool for arrhythmia prediction and detection Significant progress has been made with the Phase I STTR funding Phase II will expand the clinical research to firmly validate the neuECG as a method to estimate cardiac sympathetic tone and to develop and test prototypes that can be used for future clinical investigations while laying th groundwork for Phase III commercialization of the first application Sympathetic tone is important in cardiac arrhythmogenesis However the existing method of SNA measurement is either invasive or not accurate We have therefore developed methods to directly record SNA from either subcutaneous tissues or on the surface of the skin in canine models We found that both subcutaneous nerve activity SCNA and superficial skin sympathetic nerve activity SKNA closely correlate with stellate ganglia nerve activity SGNA in ambulatory dogs With the generous support of a Phase I STTR grant we were able to obtain preliminary results in human patients that strongly suggest the validity of SKNA in estimating sympathetic tone We have successfully developed prototypes that can be used for long term SKNA recording We will pursue the following Specific Aims Specific Aim Unequivocally validate SKNA as a highly accurate non invasive measure of skin SNA with simultaneous microelectrode recordings These studies will be performed by Dr Ronald Victor of Cedars Sinai Medical Center Specific Aim To test the hypothesis that lidocaine injection into the stellate ganglion or surgical stellectomy will reduce or eliminate the SKNA recorded from the arms These studies will be done by Dr Yong Mei Cha of the Mayo Clinic In addition to validating SKNA as a measure of skin SNA these studies may also lead to commercial applications by providing a tool to measure the success of neuromodulation procedures Specific Aim Demonstrate that SKNA as measured by neuECG can serve as a novel biomarker for testing atrial fibrillation vulnerability These studies will be done at Indiana University Our preliminary results indicate that specific SKNA patterns are closely associated with the spontaneous occurrence of paroxysmal AF Those specific patterns can be considered as novel biomarkers that are useful in arrhythmia management such as guiding radiofrequency catheter ablation procedures and predict the long term success of these procedures Successful completion of these specific aims will give Arrhythmotech LLC an excellent platform for future commercial applications PUBLIC HEALTH RELEVANCE The purpose of this STTR Phase II application is to unequivocally validate skin sympathetic nerve activity as a highly accurate non invasive measure of sympathetic tone Because sympathetic tone is important in the pathogenesis of diseases the ability to non invasively measure sympathetic tone from the skin is highly clinically significant

* Information listed above is at the time of submission. *

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