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Prolonged Local Melatonin Delivery for Recurrent Laryngeal Nerve Neuropraxia

Award Number: K08DC019957
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 12/01/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Prolonged Local Melatonin Delivery for Recurrent Laryngeal Nerve Neuropraxia - Project Summary/Abstract: This application requests a career development award for a head and neck surgeon with an interest in recurrent laryngeal nerve neuropraxia and developing prolonged methods of topical therapeutic delivery. The described career development plan will help her to build the skills in data analysis, study design, and drug delivery necessary to become an independent translational researcher developing topical therapeutics for Otolaryngology applications. The candidate’s mentorship team combines expertise from neuroscience, bioengineering, laryngology, and otolaryngology to provide a collaborative environment to help her accomplish her goals. Dr. Kita’s objectives during this mentored career development award will be: 1) Complete coursework in biostatistical methods, 2) Develop expertise in sustained-release therapeutics, and 3) Design a method of further characterizing recovery from neuropraxia in a Long Evans rat model. Manipulation of the recurrent laryngeal nerve is common in surgical procedures of the neck. Postoperative weakness can results in difficulty with speech, swallowing, and breathing. Return of function from neuropraxia, the mildest and most common form of nerve injury, often takes a few months. The impairment in communication, swallowing ability, and breathing that results can severely impact patient quality of life during this time. This award will allow the candidate to study recovery from neuropraxia and screen topical interventions for their ability to expedite recovery. Through the completion of this award, Dr. Kita will establish preliminary data and a model of neuropraxia that may be used to test therapeutics. This will be accomplished in 3 aims: 1. Design a drug-eluting hydrogel with sustained elution. Melatonin will be encapsulated in poly (lactic-co- glycolic acid) microparticles within fibrin hydrogels and elution of medication characterized. 2. Determine Schwann cell response to melatonin in vitro. Schwann cells will be grown with resuspended melatonin, filter-sterilized eluted melatonin, and with melatonin secreted from microparticles in hydrogels. 3. Create a rat model for characterizing recovery from recurrent laryngeal nerve after neuropraxia. Vocal fold movement video, electromyography readings, ultrasonography, and immunohistochemistry will be used to describe recovery after injury in a Long-Evans rat model. Drug-eluting hydrogels will be implanted and analyzed for their ability to shorten the period to recovery of vocal fold motion seen on ultrasonography. Recurrent laryngeal nerve neuropraxia is a common and debilitating complication after surgeries in the neck. Better characterization of this injury will allow insight into ways to help at risk individuals. Through this award the candidate will investigate a method of prolonged topical therapeutic delivery for its ability to assist in recovery of vocal fold function after surgical manipulation and establish the skills necessary to become an independent translational researcher.


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: 2026 ( Subtotal = $196,776 )
2026	2026	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	001	5	3/19/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$196,776
2026	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	000	4	3/11/2026	NON-COMPETING CONTINUATION	$0
2026	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	002	4	4/3/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $196,776

Issue Date FY: 2025 ( Subtotal = $201,873 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	000	4	11/21/2024	NON-COMPETING CONTINUATION	$201,873
														Subtotal = $201,873

Issue Date FY: 2024 ( Subtotal = $201,873 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	000	3	11/10/2023	NON-COMPETING CONTINUATION	$201,873
														Subtotal = $201,873

Issue Date FY: 2023 ( Subtotal = $201,873 )
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	000	2	11/21/2022	NON-COMPETING CONTINUATION	$201,873
														Subtotal = $201,873

Issue Date FY: 2022 ( Subtotal = $255,313 )
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	000	1	10/22/2021	NEW	$201,313
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research Related to Deafness and Communication Disorders	001	1	8/22/2022	SUPPLEMENT FOR EXPANSION	$54,000
														Subtotal = $255,313

Grand Total All Awards = $1,057,708

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Prolonged Local Melatonin Delivery for Recurrent Laryngeal Nerve Neuropraxia

Award Number: K08DC019957

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 12/01/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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