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Deep Brain Stimulation Probe Insertion System Utilizing Ultrasonic Vibration for Less Invasive Implantation with Improved Targeting Accuracy for Addiction Therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DA051265-01
Agency Tracking Number: R43DA051265
Amount: $333,133.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: DA19-019
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-04-01
Award End Date (Contract End Date): 2020-12-31
Small Business Information
310 ROLLING RIDGE DR
Bellefonte, PA 16823-8445
United States
DUNS: 791379030
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 RYAN CLEMENT
 (814) 355-0003
 ryan.clement@actuatedmedical.com
Business Contact
 MAUREEN MULVIHILL
Phone: (814) 355-0003
Email: maureen.mulvihill@actuatedmedical.com
Research Institution
N/A
Abstract

This Phase I SBIR develops and tests a Deep Brain Stimulation Probe Insertion System Utilizing Ultrasonic
Vibration for Less Invasive Implantation with Improved Targeting Accuracy for Addiction Therapy. This
submission is in response to: RFA –19-019 HEAL Initiative: America’s Startups and Small Businesses Build
Technologies to Stop the Opioid Crisis.
Problem to be solved: Currently, drug addiction is a major public health concern. In the U.S., more than 7
million people suffer from some type of illicit drug disorder. Due to success treating Parkinson’s and
neuropsychiatric disorders with Deep Brain Stimulation (DBS), it is being investigated as a potential drug
addiction treatment. The rationale behind addiction stimulation therapy involves reestablishing normal brain
function in target regions in an effort to dampen addictive behaviors. Targeting the Nucleus Accumbens (NA), a
key structure in the mesolimbic reward pathway, has demonstrated success preclinically as well as with human
subjects (outside the U.S.). DBS probe placement requires metal guide tube placement to mechanically
support and maintain trajectory during insertion. Placement also requires dura resection (durotomy), which
can cause brain shifts relative to the skull resulting from cerebrospinal fluid (CSF) loss and/or subdural air
invasion, decreasing accuracy of pre-surgical mapping. This project develops the Accurate DBS Placement
(ADP) system to oscillate DBS probes during insertion, allowing thinner/more flexible probes to be placed
precisely into deep neural structures, with smaller, more shallowly inserted guide tubes, or without requiring
them at all. Controlled insertion through the dura will be evaluated, which would minimize brain shifting.
Product and Long-Term Goal. The ultimate goal is to standardize/simplify the DBS procedure, making it a
more successful and attractive addiction treatment, enabling use in a wider range of surgical centers. The
product for sale – the ADP system - would be an insertion system that clinics purchase to deliver the therapy.
Additional markets exist for placing DBS electrodes for Parkinson’s disease. Initial sales will be to preclinical
researchers. Phase I Hypothesis and Aims. Hypothesis: The ADP System can enable improved DBS probe
placement accuracy with reduced overall surgical invasiveness. Aim 1: Develop and test the ADP system for
placement of multiple DBS probe styles: investigate dura and guide tube placement options. Acceptance
Criteria. andgt;70% reduction in insertion force compared to non-vibrated insertion in models and/or ex vivo tissue;
at up 10 cm insertion depth, demonstrate andlt;1 mm deviation from target path with 50% reduction in implantation
footprint. Aim 2: Demonstrate ADP system improves insertion reliability and accuracy of polymer-based MR-
compatible and flexible DBS probes into the Nucleus Accumbens (NA) in preclinical study. Acceptance
Criteria: Improved insertion success and accuracy demonstrated with the placement of ‘UNC probes’ (research
partner) into NA, verified by Magnetic Resonance Imaging (MRI) and electrophysiology recording.Project Narrative:
Relevance – The opioid crisis is having devastating effects on public health in the United States and
worldwide. New therapeutic approaches are being developed using Deep Brain Stimulation (DBS) to treat
drug addiction by stimulation of locations in the brain, like the Nucleus Accumbens. One of the main problems
is steering a long thin needle/probe safely to a deep target in the brain. The project develops a system for
accurately and safely placing a DBS probe into a target in the brain, with the goal of making DBS procedures
more viable for drug addiction treatment.

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

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