Intractable Chronic Migraine
Conditions
Brief 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
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (First 12 Weeks) | 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 | 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 | 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. |
| Migraine Disability | 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. |
| Patient Satisfaction | 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 | 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 | 3 months | Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated) |
Countries
Belgium, Germany, Luxembourg, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted Chronic Migraine Patients Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system | 112 |
| Total | 112 |
Baseline characteristics
| Characteristic | Implanted Chronic Migraine Patients |
|---|---|
| Age, Continuous | 45.9 years |
| Region of Enrollment Belgium | 3 participants |
| Region of Enrollment Germany | 83 participants |
| Region of Enrollment Luxembourg | 1 participants |
| Region of Enrollment Spain | 6 participants |
| Region of Enrollment Sweden | 1 participants |
| Region of Enrollment United Kingdom | 18 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 112 |
| serious Total, serious adverse events | 26 / 112 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted Chronic Migraine Patients | Adverse Events (First 12 Weeks) | Hardware-related AE | 17 events |
| Implanted Chronic Migraine Patients | Adverse Events (First 12 Weeks) | Biological AE | 27 events |
| Implanted Chronic Migraine Patients | Adverse Events (First 12 Weeks) | Stimulation related AE | 5 events |
| Implanted Chronic Migraine Patients | Adverse Events (First 12 Weeks) | Other AE | 1 events |
Primary
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
Population: 69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Chronic Migraine Patients | Headache Days | -16 percent change in headache days | Standard Deviation 0.71 |
Primary
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
Population: 82 patients had available data for pain relief in the previous month at the 3 month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Implanted Chronic Migraine Patients | Headache Pain Relief | 25.1 percentage pain relief |
Primary
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
Population: 63 patients had available data for all 5 questions of the Midas questionnaire computing the total score at the 3 month follow-up visit. Excluding the outliers, 59 patients had available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Chronic Migraine Patients | Migraine Disability | 74 percentage of change | Standard Deviation 6.2 |
| Midas Score Excluding 4 Outliers | Migraine Disability | -37 percentage of change | Standard Deviation 0.4 |
Primary
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)
Time frame: 3 months
Population: 84 subjects had available data for patient satisfaction at the 3 month follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted Chronic Migraine Patients | Patient Satisfaction | 28 Participants |
Primary
Physician Satisfaction
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)
Time frame: 3 months
Population: 84 subjects had available data for physician satisfaction at the 3 month follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted Chronic Migraine Patients | Physician Satisfaction | 43 Participants |
Primary
Quality of Life
Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)
Time frame: 3 months
Population: 83 subjects had available data for Quality of life at the 3 month follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted Chronic Migraine Patients | Quality of Life | 32 Participants |
Primary
Quality of Life
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)
Time frame: 3 months
Population: 84 subjects had available data for physician reported overall quality of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted Chronic Migraine Patients | Quality of Life | 43 Participants |