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Determining the Utility of a Behavioral Intervention in Chronic Migraine (RLB)

Primary Purpose

Migraine, Headache, Migraine Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Behavior Protocol
Sham Behavior Protocol
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine Disorders, Headache, Lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have chronic migraine for a minimum of 1-year
  • aged 18 years and older

Exclusion Criteria:

  • other headache disorders including secondary headache disorders
  • children younger than 18 years old
  • current pregnancy

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Virtual Therapy Group

Attention Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

Feasibility
Recruitment rate
Acceptability
Retention rate

Secondary Outcome Measures

Mean change from baseline monthly migraine frequency
Change in the mean of monthly migraine frequency
Migraine severity
severity of migraine attacks rated from 0 to 10

Full Information

First Posted
June 8, 2022
Last Updated
September 20, 2022
Sponsor
Stanford University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05415020
Brief Title
Determining the Utility of a Behavioral Intervention in Chronic Migraine
Acronym
RLB
Official Title
Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
February 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache, Migraine Disorders, Chronic Migraine, Lifestyle Factors, Headache Disorders
Keywords
Migraine Disorders, Headache, Lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Therapy Group
Arm Type
Active Comparator
Arm Title
Attention Placebo Group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Behavior Protocol
Intervention Description
Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks
Intervention Type
Behavioral
Intervention Name(s)
Sham Behavior Protocol
Intervention Description
Virtual training on the disease of migraine and how migraine can progress to chronic migraine.
Primary Outcome Measure Information:
Title
Feasibility
Description
Recruitment rate
Time Frame
12 weeks
Title
Acceptability
Description
Retention rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline monthly migraine frequency
Description
Change in the mean of monthly migraine frequency
Time Frame
12 weeks
Title
Migraine severity
Description
severity of migraine attacks rated from 0 to 10
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Headache self-efficacy
Description
Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome.
Time Frame
12 weeks
Title
Levels of candidate biomarkers
Description
Using mass spectrometry, serum levels of candidate biomarkers acryloyl-CoA, glutaminylhistidine, HABP2 will be compared at baseline and end of study (end of week-12)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have chronic migraine for a minimum of 1-year aged 18 years and older Exclusion Criteria: other headache disorders including secondary headache disorders children younger than 18 years old current pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Yohannes Woldeamanuel, MD
Phone
650-721-2830
Email
ywoldeam@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Yohannes Woldeamanuel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu P Rajasekaran, MS
Phone
650-304-6402
Email
bpriya@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication, for 5 years
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Citations:
PubMed Identifier
34357593
Citation
Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.
Results Reference
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PubMed Identifier
32973989
Citation
Woldeamanuel YW, Sanjanwala BM, Cowan RP. Endogenous glucocorticoids may serve as biomarkers for migraine chronification. Ther Adv Chronic Dis. 2020 Jul 21;11:2040622320939793. doi: 10.1177/2040622320939793. eCollection 2020.
Results Reference
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PubMed Identifier
32071349
Citation
Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1.
Results Reference
background
PubMed Identifier
30468246
Citation
Woldeamanuel YW, DeSouza DD, Sanjanwala BM, Cowan RP. Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study. Headache. 2019 Feb;59(2):180-191. doi: 10.1111/head.13452. Epub 2018 Nov 23.
Results Reference
background
PubMed Identifier
28017235
Citation
Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
Results Reference
background
PubMed Identifier
26810728
Citation
Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25.
Results Reference
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Determining the Utility of a Behavioral Intervention in Chronic Migraine

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