Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

Abbott Medical Devices112 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Intractable Chronic Migraine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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: * NA

Locations (18)

Heilig Hartziekenhuis

Roeselare, West-Vlaanderen, Belgium

Centre Hospitalier Régional de la CITADELLE

Liège, Belgium

Outcomes

Primary Outcomes

Adverse Events (First 12 Weeks)

Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.

Time frame: 3 months

Headache Pain Relief

Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked "in the last month", how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)

Time frame: 3 months

Headache Days

Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.

Time frame: 3 months

Migraine Disability

Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.

Time frame: 3 months

Patient Satisfaction

Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)

Data from ClinicalTrials.gov

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