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The DMPFC as a target in treatment-resistant Bulimia Nervosa and Anorexia Nervosa:investigating target engagement, dosing, reliability and duration of effect using rTMS, fMRI,and a sham controlled arm

Award Number: R61MH110034
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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The DMPFC as a target in treatment-resistant Bulimia Nervosa and Anorexia Nervosa:investigating target engagement, dosing, reliability and duration of effect using rTMS, fMRI,and a sham controlled arm - PROJECT SUMMARY This project investigates the utility of dorsomedial prefrontal cortex(DMFPC) repetitive transcranial magnetic stimulation (rTMS) in bingeing and purging in chronic, treatment- resistant bulimia nervosa(BN), and anorexia nervosa, binge-purging subtype(ANBN). rTMS uses powerful, focused magnetic field pulses to change activity in target brain regions. Published pilot work shows 57% of those treated with DMPFC rTMS for bingeing and purging experience both a >50% reduction in both bingeing and purging, and a wide variety of improvements in other domains, including mood, anxiety, and affective regulation. Response in terms of reduced bingeing and purging does not appear to be correlated to other comorbidity. Response is heavily correlated to pre-treatment fronto- striatal connectivity as measured by functional magnetic resonance imaging(frmi), where responders have a consistent pattern of poor connectivity initially compared to non- responders, which pattern normalizes over the course of treatment The aims of the proposed R61/33 phased trial are to 1) confirm target engagement and determine an optimal dosing paradigm(R61 phase); and 2) ensure that the results are not due to a placebo effect, determine the clinical effectiveness and duration of effect, and begin to examine the potential use of pre-treatment fMRI as a biomarker of treatment suitability(R33 phase). Subjects in the R61 arm will undergo 30 bilateral rTMS treatments accompanied by a suite of imaging, clinical, psychometric, and psychological test assessments, in two dosage regimens and a sham arm. In the R33 phase, the optimal dosing regimen will be used with a novel active/sham coil to administer 20 rTMS treatments in a triple blind design. Subjects will again be assessed as in the R61 phase. If successful, the study will provide evidence for the future development of rTMS as a novel, effective treatment for refractory BN and ANBP, and further information as to the neural mechanisms both of the illnesses and the mechanism of response to rTMS.


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: 2022 ( Subtotal = $0 )
2022	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON			CAN	Mental Health Research Grants	000	2	10/27/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	000	2	4/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	000	2	3/15/2019	NON-COMPETING CONTINUATION	$0
2019	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	002	2	6/1/2019	NON-COMPETING CONTINUATION	$0
2019	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	001	1	4/16/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $433,693 )
2018	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	000	2	6/15/2018	NON-COMPETING CONTINUATION	$433,693
														Subtotal = $433,693

Issue Date FY: 2017 ( Subtotal = $435,853 )
2017	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Mental Health Research Grants	000	1	5/23/2017	NEW	$435,853
														Subtotal = $435,853

Grand Total All Awards = $869,546

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The DMPFC as a target in treatment-resistant Bulimia Nervosa and Anorexia Nervosa:investigating target engagement, dosing, reliability and duration of effect using rTMS, fMRI,and a sham controlled arm

Award Number: R61MH110034

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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