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Targeted Neural Plasticity for the Treatment of Tinnitus

Award Number: U44DC010084
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/23/2009
PERIOD OF PERFORMANCE END DATE: 07/31/2016

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Targeted Neural Plasticity for the Treatment of Tinnitus - DESCRIPTION (provided by applicant): This is a proposal to conduct a multi-center, double-blind, sham-controlled partial cross-over interventional study to test safety and efficacy of our novel tinnitus therapy. The tinnitus field generally accepts that elevated synchronous spontaneous activity in the auditory cortex may account for the tinnitus percept that arises following hearing loss. Following hearing loss that leads to tinnitus, some neurons in the auditory cortex start responding to adjacent frequencies and therefore, a population of neurons becomes over stimulated and starts firing spontaneously and synchronously. This pathological activity is thought to give rise to the tinnitus sensation. Based on these considerations, we developed an approach to reduce the tinnitus percept by redistributing the frequencies along the auditory tonotopic axis, thus reducing the responsiveness of neurons that had too much input. Our therapy pairs selected tone presentations with simultaneous stimulation of the vagus nerve to induce a redistribution of the distorted auditory cortical frequency map observed in tinnitus. Based on our SBIR Phase I results, this approach seemed to alleviate the presumed behavioral and neurophysiological correlates of tinnitus in a rat model of the disease. In our SBIR Phase II studies, we further evaluated and validated the stimulation conditions for reducing the tinnitus precept in our chosen animal model. Based on these positive findings in animals, we evaluated our approach as a therapy for tinnitus in seven humans in a clinical Phase I study in Europe. The preliminary results of that small study suggest that our therapy is safe and can be highly effective in some people. Based on this successful clinical Phase I study, we are seeking to more fully evaluate our therapy in a larger cohort (30 people) using an SBIR Phase II competing renewal award (SBIR Phase IIb). Criteria for Success: We must reduce the magnitude the tinnitus as measured by the minimum masking level. To our knowledge, no masking or pharmacological treatment for tinnitus has reliably reduced this measure. Based on our preliminary findings in humans, we expect that our treatment will reduce the primary measure by 7 dB or more in at least 50% of subjects and the reductions will last for months. A clinically significant MML change is any value greater than 5 dB. Numerous standard subjective measures of tinnitus are also expected to show a reduction or trend toward reduction. No serious adverse events that can be attributed to our therapy should be observed. A successful trial will lead to a clinical Phase III double-blind efficacy study and mechanistic studies. If the Phase III trial is successful, we expect to deploy a commercial device immediately following FDA approval.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = $1,354,163 )
2017	2013	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	001	5	12/21/2016	NON-COMPETING CONTINUATION	-$1,216,261
2017	2013	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	005	5	5/4/2017	NON-COMPETING CONTINUATION	$1,216,261
2017	2013	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	004	5	5/4/2017	NON-COMPETING CONTINUATION	$1,216,261
2017	2013	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	006	5	5/4/2017	NON-COMPETING CONTINUATION	$0
2017	2012	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	003	4	5/4/2017	COMPETING CONTINUATION	$137,902
2017	2012	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	000	4	12/21/2016	COMPETING CONTINUATION	-$137,902
2017	2012	MICROTRANSPONDER	2802 FLINTROCK TRACE STE 226	AUSTIN	TX	78738	TRAVIS	USA	Research Related to Deafness and Communication Disorders	002	4	5/4/2017	COMPETING CONTINUATION	$137,902
														Subtotal = $1,354,163

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2013	MICRO TRANSPONDER INC	12147 LUEDERS STREET	DALLAS	TX	75230	DALLAS	USA	Research Related to Deafness and Communication Disorders	000	5	7/30/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $1,216,261 )
2013	2013	MICRO TRANSPONDER INC	12147 LUEDERS STREET	DALLAS	TX	75230	DALLAS	USA	Research Related to Deafness and Communication Disorders	000	5	7/26/2013	NON-COMPETING CONTINUATION	$1,216,261
														Subtotal = $1,216,261

Issue Date FY: 2012 ( Subtotal = $1,354,163 )
2012	2012	MICRO TRANSPONDER INC	12147 LUEDERS STREET	DALLAS	TX	75230	DALLAS	USA	Research Related to Deafness and Communication Disorders	000	4	8/9/2012	COMPETING CONTINUATION	$1,354,163
														Subtotal = $1,354,163

Grand Total All Awards = $3,924,587

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Targeted Neural Plasticity for the Treatment of Tinnitus

Award Number: U44DC010084

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/23/2009

PERIOD OF PERFORMANCE END DATE: 07/31/2016

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