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Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

Award Number: K01NS124911
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/30/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine - Project Summary: This K01 NINDS Award will provide Dr. Yohannes Woldeamanuel with intensive, supervised training to help him become an independent research scientist focusing on headache medicine, more specifically on managing migraine using health-promoting lifestyle behaviors (e.g. regular exercise). Using this K01 Award, Dr. Woldeamanuel will get the support necessary to complete the following goals: (a) become skilled in clinical trials involving behavioral interventions to manage migraine, (b) train in statistical and bioinformatics methods, (c) to gain proficiency in mass spectrometry, assays, and quantification, (d) develop activities and scholarship aimed at career development goals to become an independent investigator. To achieve these goals, Dr. Woldeamanuel has assembled a team of mentors: Drs. Robert Cowan (Primary Mentor), Oxana Palesh (Co- Mentor), Jamie Zeitzer (Co-Mentor), Michael Snyder (Co-Mentor), Ying Lu (Advisor), Allis Chien (Advisor). Research: Increasingly, migraine patients prefer non-drug treatment options and often discontinue drug treatment due to adverse effects, poor compliance, and cost issues. Currently, there is no direct evidence demonstrating the utility of regular lifestyle behavior (RLB i.e. regular sleep, exercise, mealtime) to manage chronic migraine. This proposal is the first to conduct a feasibility and pilot testing study of RLB in managing chronic migraine using the following specific aims. Primary Aim: To determine the feasibility and acceptability of RLB in chronic migraine patients. Secondary Aim: To examine the preliminary efficacy of RLB in managing chronic migraine as measured by reduction in monthly migraine days. Mechanistic Exploratory Aim: To examine candidate biomarkers that predict chronic migraine patients who are RLB-responders. The development, pilot testing, and validation RLB-based migraine therapy will have a positive impact in the headache field by providing a framework for development of efficacious lifestyle-based self-management protocols. By demonstrating it to be equipotent to daily medications, lifestyle medicine can have the added value of obviating medication risks and unwanted side-effects common among chronic migraine sufferers. The proposed research is innovative because its successful completion will pilot test a novel method by utilizing RLB as a self-management tool in managing migraine. In addition, this proposed research will use multi-omics to elucidate underlying biological mechanisms of RLB therapy. Application of system biology technology will create a paradigm shift from current headache research concentrating on single molecule. This approach will be the first of its kind in the headache field in providing proof-of-principle that personalized lifestyle-based protocols can be used to manage migraine. This research will form the basis for an R01 application of a full-scale clinical trial before the end of the K award.


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: 2025 ( Subtotal = $240,354 )
2025	2025	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	9/12/2025	NON-COMPETING CONTINUATION	$0
2025	2025	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	8/18/2025	NON-COMPETING CONTINUATION	$240,354
2025	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	2/24/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $240,354

Issue Date FY: 2024 ( Subtotal = $240,354 )
2024	2024	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	9/20/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$240,354
2024	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	9/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $240,354

Issue Date FY: 2023 ( Subtotal = $240,354 )
2023	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/23/2023	NON-COMPETING CONTINUATION	$240,354
														Subtotal = $240,354

Issue Date FY: 2022 ( Subtotal = $240,354 )
2022	2022	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/20/2022	NON-COMPETING CONTINUATION	$240,354
														Subtotal = $240,354

Issue Date FY: 2021 ( Subtotal = $240,354 )
2021	2021	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/24/2021	NEW	$240,354
														Subtotal = $240,354

Grand Total All Awards = $1,201,770

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Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

Award Number: K01NS124911

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/30/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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