Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

Migraine Disability

时间窗: 3 months

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.

Adverse Events (First 12 Weeks)

时间窗: 3 months

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.

Headache Pain Relief

时间窗: 3 months

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)

Headache Days

时间窗: 3 months

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.

Patient Satisfaction

时间窗: 3 months

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)

Physician Satisfaction

时间窗: 3 months

Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)

Quality of Life

时间窗: 3 months

Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)