Targeted Neural Plasticity for the Treatment of Tinnitus

Information

  • Research Project
  • 8067867
  • ApplicationId
    8067867
  • Core Project Number
    R44DC010084
  • Full Project Number
    5R44DC010084-03
  • Serial Number
    10084
  • FOA Number
    PA-08-146
  • Sub Project Id
  • Project Start Date
    3/23/2009 - 15 years ago
  • Project End Date
    4/30/2013 - 11 years ago
  • Program Officer Name
    MILLER, ROGER
  • Budget Start Date
    5/1/2011 - 13 years ago
  • Budget End Date
    4/30/2013 - 11 years ago
  • Fiscal Year
    2011
  • Support Year
    3
  • Suffix
  • Award Notice Date
    5/6/2011 - 13 years ago
Organizations

Targeted Neural Plasticity for the Treatment of Tinnitus

DESCRIPTION (provided by applicant): In Phase I, we demonstrated the feasibility of using VNS stimulation paired with tone presentations to completely reverse the effects of tinnitus in a rat model of the disease. The Specific Aim of Phase II is to accumulate data for the submission of an IDE application for testing the safety and efficacy of our therapeutic VNS device in humans. Approximately 12 million individuals in the United States have been diagnosed with tinnitus of which ~1 million have severe tinnitus interfering with their daily activities. Although many advances have been made in symptomatic treatments, these treatments are unable to eliminate the tinnitus sensation in most patients. Our therapeutic device will use a PC based software package to allow for computer controlled VNS to be paired with the presentation of tones. This system will be easily deployable as a laptop PC driven rehabilitation therapy device. We have partnered with Texcel (East Longmeadow, MA) to use their StimX VNS stimulation device and software to deliver our therapy in the clinic. The Texcel system is currently in clinical trials for an unrelated indication. While we have proven the feasibility of pairing tone and VNS to reverse tinnitus in rats in Phase I, we must now investigate stimulus parameters more thoroughly in order to develop a rational protocol for humans. VNS parameters have translated well from rats to humans for epilepsy, depression, and learning. It therefore seems reasonable to use a rat model of tinnitus to set the first order parameters for treating tinnitus in humans. Along these same lines, it seems reasonable to use a rat model to evaluate several possible clinical confounds that might occur. In addition, while obtaining FDA approval for testing therapies in humans does not require a mechanistic explanation;experience has shown this to be very useful;we will investigate such a mechanism at a very high level. In parallel to these animal studies, we will be developing the software needed to drive the StimX device at the appropriate parameters for tinnitus therapy. The software is not currently designed to stimulate at our desired parameters. Finally, we will test the software modification and our proposed initial clinical stimulation protocol for efficacy in a rat model of tinnitus. If this final test is successful, we will then assemble and file an IDE for clinical testing. Filing this IDE will conclude a successful Phase II study. We expect to start a clinical trail within 90 days of concluding this Phase II study. If VNS-induced plasticity is effective in treating tinnitus in patients, the technology may also be useful to treat other neurological conditions, including stroke, chronic pain, and epilepsy by pairing each of these conditions with appropriate external cues to retrain pathologically altered neural circuits. PUBLIC HEALTH RELEVANCE: This is a Phase II SBIR application to develop a therapy for tinnitus. Our Phase I studies demonstrated that our overall therapeutic approach can induce lasting and complete reverse of tinnitus using a safe and inexpensive method of vagal nerve stimulation paired with presentation of sounds. Tinnitus is a devastating disease for millions of Americans. Severe forms of tinnitus are debilitating and untreated. This project will move our therapy toward clinical trials to test efficacy in humans.

IC Name
NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
  • Activity
    R44
  • Administering IC
    DC
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    1133019
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    173
  • Ed Inst. Type
  • Funding ICs
    NIDCD:1133019\
  • Funding Mechanism
    SBIR-STTR
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    MICROTRANSPONDER, INC.
  • Organization Department
  • Organization DUNS
    793502068
  • Organization City
    AUSTIN
  • Organization State
    TX
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    787381743
  • Organization District
    UNITED STATES