Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01NS124911 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Therapy Group | Active Comparator |
| |
| Attention Placebo Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Behavior Protocol | Behavioral | Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Interested Participants that are Enrolled | Recruitment rate (Feasibility Outcome) | 12 weeks |
| Acceptability | Retention rate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline monthly migraine frequency | Change in the mean of monthly migraine frequency | 12 weeks |
| Migraine severity | severity of migraine attacks rated from 0 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Headache self-efficacy | Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome. | 12 weeks |
| Levels of candidate biomarkers |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yohannes W. Woldeamanuel, MD | Contact | 650-933-3560 | Woldeamanuel.YohannesWoubishet@mayo.edu | |
| Migraine Study | Contact | 480-342-1385 | azmigrainetrial@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Yohannes W. Woldeamanuel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34357593 | Background | 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. | |
| 32973989 | Background | 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. |
Not provided
Not provided
all IPD that underlie results in a publication
starting 6 months after publication, for 5 years
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).
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Behavior Protocol | Behavioral | Virtual training on the disease of migraine and how migraine can progress to chronic migraine. |
|
| 12 weeks |
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)
| 12 weeks |
| 32071349 | Background | 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. |
| 30468246 | Background | 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. |
| 28017235 | Background | 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. |
| 26810728 | Background | 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |