Intractable Chronic Migraine Clinical Trial
— ReliefOfficial title:
Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
| Verified date | January 2019 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- 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: |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Centre Hospitalier Régional de la CITADELLE | Liège | |
| Belgium | Heilig Hartziekenhuis | Roeselare | West-Vlaanderen |
| Germany | Neurologische Klinik und Poliklinik Charité Campus Mitte | Berlin | |
| Germany | Klinikum Delmenhorst GmbH | Delmenhorst | Großherzogtum Oldenburg |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | Nordrhein-Westfalen |
| Germany | Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie | Essen | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Essen | Essen | Nordrhein-Westfalen |
| Germany | Schmerzklinik und Praxis an der Schmerzklinik Kiel | Kiel | Schleswig-Holstein |
| Germany | Migräne and Kopfschmerzklinik Königstein | Königstein | Saksen |
| Luxembourg | Centre Hospitalier de Luxembourg | Luxembourg | |
| Spain | Hospital Puerta de Hierro | Madrid | |
| Spain | Hospital Universitario | Madrid | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | Andalucia |
| Sweden | Karolinska Hospital | Stockholm | Stockholms Län |
| United Kingdom | Seacroft Hospital | Leeds | Yorkshire |
| United Kingdom | King's College Hospital | London | |
| United Kingdom | Royal London Hospital | London | Royal London Hospital |
| United Kingdom | John Radcliffe hospital | Oxford | Oxfordshire |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
Belgium, Germany, Luxembourg, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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) | 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. | 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. | 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) | 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) | 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) | 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) | 3 months |