Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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. | 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. | 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) |
Not provided
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients diagnosed with intractable chronic migraine and implanted with a St.Jude Medical conformité européenne approved implantable neurostimulation system
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilig Hartziekenhuis | Roeselare | West-Vlaanderen | 8800 | Belgium | ||
| Centre Hospitalier Régional de la CITADELLE |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| 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) | 3 months |
| 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) | 3 months |
| 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) | 3 months |
| Liège |
| 4000 |
| Belgium |
| Klinikum Delmenhorst GmbH | Delmenhorst | Großherzogtum Oldenburg | 27753 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | 81377 | Germany |
| Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie | Essen | North Rhine-Westphalia | 45133 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Migräne and Kopfschmerzklinik Königstein | Königstein | Saxony | 61462 | Germany |
| Schmerzklinik und Praxis an der Schmerzklinik Kiel | Kiel | Schleswig-Holstein | 24129 | Germany |
| Neurologische Klinik und Poliklinik Charité Campus Mitte | Berlin | 10117 | Germany |
| Centre Hospitalier de Luxembourg | Luxembourg | 1210 | Luxembourg |
| Hospital Universitario Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Universitario | Madrid | 28046 | Spain |
| Hospital Puerta de Hierro | Madrid | 28222 | Spain |
| Karolinska Hospital | Stockholm | Stockholm County | 17176 | Sweden |
| John Radcliffe hospital | Oxford | Oxfordshire | OX39DU | United Kingdom |
| Royal London Hospital | London | Royal London Hospital | E1 1BB | United Kingdom |
| Seacroft Hospital | Leeds | Yorkshire | LS146UH | United Kingdom |
| King's College Hospital | London | sE5 9NT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | events | 3 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| 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) | 82 patients had available data for pain relief in the previous month at the 3 month follow-up visit | Posted | Mean | Full Range | percentage pain relief | 3 months |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit | Posted | Mean | Standard Deviation | percent change in headache days | 3 months |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change | 3 months |
|
| ||||||||||||||||||||||||||||||||||||
| 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) | 84 subjects had available data for patient satisfaction at the 3 month follow-up visit. | Posted | Count of Participants | Participants | 3 months |
|
| |||||||||||||||||||||||||||||||||||||
| 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) | 84 subjects had available data for physician satisfaction at the 3 month follow-up visit. | Posted | Count of Participants | Participants | 3 months |
|
| |||||||||||||||||||||||||||||||||||||
| 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) | 83 subjects had available data for Quality of life at the 3 month follow-up visit. | Posted | Count of Participants | Participants | 3 months |
|
| |||||||||||||||||||||||||||||||||||||
| 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) | 84 subjects had available data for physician reported overall quality of life | Posted | Count of Participants | Participants | 3 months |
|
|
12 weeks
Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 who experienced a Serious Device related adverse event | 26 | 112 | 7 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breakage/facture of the extension | Product Issues |
| |||
| Device Malfunction | Product Issues |
| |||
| IPG migration | Skin and subcutaneous tissue disorders |
| |||
| Infection: IPG and lead site | Infections and infestations |
| |||
| Infection: lead site only | Infections and infestations |
| |||
| Lead breakage/fracture | Product Issues |
| |||
| Lead migration | Skin and subcutaneous tissue disorders |
| |||
| persistant pain and/or numbness: IPG site only | Skin and subcutaneous tissue disorders |
| |||
| persistant pain and/or numbness: lead site only | Skin and subcutaneous tissue disorders |
| |||
| persistent pain at connector site | Skin and subcutaneous tissue disorders |
| |||
| skin erosion | Skin and subcutaneous tissue disorders |
| |||
| Wound site complications | Skin and subcutaneous tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent pain and/or numbness | Surgical and medical procedures | For 7 patients, there were reports of persistent pain and/or numbness at the lead and/or IPG site |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Director | St Jude Medical/Abbott | rdiaz@sjm.com |
| Luxembourg |
|
| United Kingdom |
|
| Germany |
|
| Spain |
|
| Title | Measurements |
|---|---|
|
| Other AE |
|
|
|
| Participants |
|
|
|
|
|
|