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Central mechanisms and treatment response of sodium oxybate in spasmodic dysphonia and voice tremor

Award Number: R01DC012545
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/17/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Central mechanisms and treatment response of sodium oxybate in spasmodic dysphonia and voice tremor - Spasmodic dysphonia, or laryngeal dystonia, is a chronic debilitating condition that selectively affects speech production due to involuntary spasms in the laryngeal muscles. SD often extends beyond vocal communication impairment and causes significant occupational disability and life-long social isolation. SD becomes even more incapacitating when it is associated with dystonic voice tremor (VT), which is present in about 1/3 of SD patients and is characterized by the inability to sustain a vowel for more than a few seconds. Current treatment of these disorders is limited to the temporary management of voice symptoms with repeated injections of botulinum toxin into the laryngeal muscles, which, however, are not effective in all SD patients and even less so in combined SD/VT cases. There is, therefore, a critical need to identify alternative therapeutic options that are specifically targeting the pathophysiology of SD and VT. On the other hand, the design and use of such novel therapeutic approaches will be largely unattainable if their central mechanisms of action remain unknown. Our long-term goal is to determine the pathophysiology of SD and related disorders, such as VT, and develop new diagnostic and treatment options for these patients. The objective of this application is to elucidate the primary determinants of clinical response to a novel oral medication, sodium oxybate (Xyrem®), in alcohol-responsive SD and SD/VT patients. Our central hypothesis is that clinical benefits of sodium oxybate are contingent upon selective modulation of neural alterations associated with genetics susceptibility factors that underlie symptom responsiveness to alcohol in SD and VT. Using a comprehensive approach of clinico- behavioral testing, neuroimaging and pharmacogenetics, our central hypothesis will be tested by pursuing two specific aims, which will: (1) determine the clinical response of SD and VT symptoms to sodium oxybate, and (2) identify primary markers of clinical benefits of sodium oxybate in these disorders. This research is innovative because it will use a controlled experimental design that focuses on detailed characterization of primary effects of a novel oral medication, sodium oxybate, for treatment of SD and VT symptoms. The proposed research is significant because it is expected to have broad translational impact on improving the clinical management of patients with SD and VT, opening new therapeutic horizons for treatment of these and similar disorders.


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 = $0 )
2026	2021	MASSACHUSETTS EYE AND EAR INFIRMARY	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	10	1/5/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	MASSACHUSETTS EYE AND EAR INFIRMARY	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	10	8/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	MASSACHUSETTS EYE AND EAR INFIRMARY & PHYSICIAN STAFF, INC.	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	10	6/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $614,041 )
2021	2021	MASSACHUSETTS EYE AND EAR INFIRMARY & PHYSICIAN STAFF, INC.	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	10	8/17/2021	NON-COMPETING CONTINUATION	$614,041
														Subtotal = $614,041

Issue Date FY: 2020 ( Subtotal = $614,041 )
2020	2020	MASSACHUSETTS EYE AND EAR INFIRMARY & PHYSICIAN STAFF, INC.	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	9	8/14/2020	NON-COMPETING CONTINUATION	$614,041
														Subtotal = $614,041

Issue Date FY: 2019 ( Subtotal = $614,041 )
2019	2019	MASSACHUSETTS EYE AND EAR INFIRMARY & PHYSICIAN STAFF, INC.	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	8	8/14/2019	NON-COMPETING CONTINUATION	$614,041
														Subtotal = $614,041

Issue Date FY: 2018 ( Subtotal = $614,041 )
2018	2018	MASSACHUSETTS EYE AND EAR INFIRMARY & PHYSICIAN STAFF, INC.	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Research Related to Deafness and Communication Disorders	000	7	8/15/2018	NON-COMPETING CONTINUATION	$614,041
														Subtotal = $614,041

Issue Date FY: 2017 ( Subtotal = $631,541 )
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Research Related to Deafness and Communication Disorders	002	6	9/19/2017	COMPETING CONTINUATION	$132,164
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Research Related to Deafness and Communication Disorders	000	6	8/4/2017	COMPETING CONTINUATION	$631,541
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Research Related to Deafness and Communication Disorders	004	6	9/21/2017	COMPETING CONTINUATION	-$1,049
2017	2016	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Research Related to Deafness and Communication Disorders	003	5	9/21/2017	EXTENSION WITH OR WITHOUT FUNDS	$1,049
2017	2016	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Research Related to Deafness and Communication Disorders	001	5	9/19/2017	EXTENSION WITH OR WITHOUT FUNDS	-$132,164
														Subtotal = $631,541

Issue Date FY: 2016 ( Subtotal = $422,206 )
2016	2016	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL, BOX 3500	NEW YORK-NEW YORK	NY	10029		USA	Research Related to Deafness and Communication Disorders	000	5	6/22/2016	EXTENSION WITH OR WITHOUT FUNDS	$422,206
														Subtotal = $422,206

Issue Date FY: 2015 ( Subtotal = $417,984 )
2015	2015	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL, BOX 3500	NEW YORK-NEW YORK	NY	10029		USA	Research Related to Deafness and Communication Disorders	000	4	6/18/2015	NON-COMPETING CONTINUATION	$417,984
														Subtotal = $417,984

Issue Date FY: 2014 ( Subtotal = $422,206 )
2014	2014	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL, BOX 3500	NEW YORK-NEW YORK	NY	10029		USA	Research Related to Deafness and Communication Disorders	000	3	6/24/2014	NON-COMPETING CONTINUATION	$422,206
														Subtotal = $422,206

Issue Date FY: 2013 ( Subtotal = $401,096 )
2013	2013	MT SINAI SCHOOL OF MEDICINE	1 GUSTAVE L LEVY PL, BOX 3500	NEW YORK-NEW YORK	NY	10029		USA	Research Related to Deafness and Communication Disorders	000	2	6/17/2013	NON-COMPETING CONTINUATION	$401,096
														Subtotal = $401,096

Issue Date FY: 2012 ( Subtotal = $425,747 )
2012	2012	MT SINAI SCHOOL OF MEDICINE	1 GUSTAVE L LEVY PL, BOX 3500	NEW YORK-NEW YORK	NY	10029		USA	Research Related to Deafness and Communication Disorders	000	1	7/17/2012	NEW	$425,747
														Subtotal = $425,747

Grand Total All Awards = $5,176,944

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Central mechanisms and treatment response of sodium oxybate in spasmodic dysphonia and voice tremor

Award Number: R01DC012545

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/17/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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