N/A N=112

Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

Intractable Chronic Migraine

Bottom Line

View on ClinicalTrials.gov: NCT02227758 ↗

Enrolled (actual)

112

Serious AEs

23.2%

Results posted

Dec 2018

Primary outcome: Primary: Adverse Events (First 12 Weeks) — 17; 27; 5; 1 events

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events (First 12 Weeks)	17; 27; 5; 1	—
PRIMARY Headache Pain Relief	25.1	—
PRIMARY Headache Days	-16	—
PRIMARY Migraine Disability	74; -37	—
PRIMARY Patient Satisfaction	28	—
PRIMARY Physician Satisfaction	43	—
PRIMARY Quality of Life	43	—
PRIMARY Quality of Life	43	—

Summary

The purpose of this study is to evaluate the long-term safety and performance of neurostimulation for the treatment of intractable chronic migraine as well as to detect infrequent complications or problems only apparent in "real-world" practice

Eligibility Criteria

Patient is 18 years of age or older.
Patient has signed and received a copy of the Informed Consent form;
Patient has been implanted with a St. Jude Medical CE approved implantable neurostimulation system for the treatment of intractable chronic migraine:
Patient diagnosed with chronic migraine (15 or more days per month with headache lasting at least 4 hours per day)
Patient has failed three or more preventative drugs for treatment of their migraine
Patient has at least moderate disability determined using a validated migraine disability instrument [e.g., MIDAS >11 or HIT-6 >56]

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02227758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.