NCT06077812Completed
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
The investigators aim to determine the feasibility of a migraine self-management program.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 5 Oct 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 6 Aug 2024
- Lead sponsor
- NYU Langone Health
- Diseases
- Migraine
- NCT number
- NCT06077812
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 27 Nov 2023 to the primary completion date, 6 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of Medication Overuse Headache (MOH)
- Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy for migraine in the past year
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to develop medication overuse headache)
Other illness
- Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II
Other
- Current opioid or barbiturate use
- Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
- Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
- Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied
Who the study is looking for
- English speaking. (At this time, the validated app is only available in English.)
- 18-65 years of age
- Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
- Headaches for ≥1 year
- Has not begun a new migraine preventative medication in the last month
- Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds)
- 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment \[\>4 headache days/month\] and those with more frequent migraines including chronic migraine \[15 days or more/month\] but exclude those with continuous headaches)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
- Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis.Cephalalgia · 2026 · PMID 42220255
This page is information, not medical advice. Discuss any trial with your doctor.