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

Information

  • Research Project
  • 10013712
  • ApplicationId
    10013712
  • Core Project Number
    R43DA051265
  • Full Project Number
    1R43DA051265-01
  • Serial Number
    051265
  • FOA Number
    RFA-DA-19-019
  • Sub Project Id
  • Project Start Date
    4/1/2020 - 4 years ago
  • Project End Date
    12/31/2020 - 3 years ago
  • Program Officer Name
    ANGELONE, LEONARDO MARIA
  • Budget Start Date
    4/1/2020 - 4 years ago
  • Budget End Date
    12/31/2020 - 3 years ago
  • Fiscal Year
    2020
  • Support Year
    01
  • Suffix
  • Award Notice Date
    3/30/2020 - 4 years ago
Organizations

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

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. >70% reduction in insertion force compared to non-vibrated insertion in models and/or ex vivo tissue; at up 10 cm insertion depth, demonstrate <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.

IC Name
NATIONAL INSTITUTE ON DRUG ABUSE
  • Activity
    R43
  • Administering IC
    DA
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    333133
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    279
  • Ed Inst. Type
  • Funding ICs
    NIDA:333133\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZDA1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ACTUATED MEDICAL, INC.
  • Organization Department
  • Organization DUNS
    791379030
  • Organization City
    BELLEFONTE
  • Organization State
    PA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    168238445
  • Organization District
    UNITED STATES