Treatment of severe chronic migraines with injections of stem cells obtained from patients' own fat tissue

Completed

Conditions: Chronic migraine, refractory to treatment
Nervous System Diseases

Registration Number: ISRCTN72512465

Lead Sponsor: ew York Headache Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. Aged 18 years and over
2. Suffer from refractory chronic migraines, defined as patients with severe migraine-related disability as measured by the migraine disability assessment (MIDAS) score
3. Failed to respond to at least 3 prophylactic medications and onabotulinumtoxinA

Exclusion Criteria

1. Pregnancy
2. Low body mass index

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in migraine-related disability, as measured by patient-reported Migraine Disability Assessment (MIDAS) score, in the three months following the procedure.

Secondary Outcome Measures

Name	Time	Method
1. The change in impact of headaches as measured by the Headache impact score (HIT-6) in the third month compared to the month prior to the procedure<br>2. Patient's global impression of change is measured using a standard verbal scale at baseline and 3 months after the procedure<br>3. Clinician’s global Impression of change is measured using a standard verbal scale at baseline and 3 months after the procedure <br>4. Number of headache-free days are measured using a daily diary in the month preceding the procedure and in the third month following the procedure<br>5. Percentage of patients with 50% or greater reduction in headache-free days is measured using a daily diary in the month preceding the procedure and in the third month following the procedure<br>6. Number and type of abortive migraine medications taken is measured using a daily diary in the month preceding the procedure and in the third month following the procedure