RecruitingNot Applicable

Mind Body Intervention for Chronic Migraine Headaches

United States10 participantsStarted 2024-11-15

Plain-language summary

The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult (≥ 18 years of age)
✓. Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
✓. A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
✓. Presence of migraine headaches at least 5 days per month
✓. Willing to engage in a Mind-Body intervention
✓. Willing/able to participate in remote sessions

Exclusion criteria

✕. Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
✕. Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
✕. Diagnosis of cognitive impairment or dementia
✕. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
✕. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.

What they're measuring

MIDAS

Timeframe: baseline, 4, 8, 13 and 20 weeks

HIT-6

Timeframe: baseline, 4, 8, 13 and 20 weeks

Trial details

NCT IDNCT06690060

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Ashley Scafetta

617-754-2882 ascafett@bidmc.harvard.edu

View on ClinicalTrials.gov More Migraines trials