Clinical trial NCT02227758: Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
Official title: Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intractable Chronic Migraine
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with intractable chronic migraine and implanted with a St.Jude Medical conformité européenne approved implantable neurostimulation system

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


Eligibility 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

Primary outcomes:
measure: Adverse Events (First 12 Weeks)
timeFrame: 3 months
measure: Headache Pain Relief
timeFrame: 3 months
measure: Headache Days
timeFrame: 3 months
measure: Migraine Disability
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 3 months
measure: Physician Satisfaction
timeFrame: 3 months
measure: Quality of Life
timeFrame: 3 months
measure: Quality of Life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: Heilig Hartziekenhuis
state: West-Vlaanderen
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la CITADELLE
city: Delmenhorst
country: Germany
facility: Klinikum Delmenhorst GmbH
state: Großherzogtum Oldenburg
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Königstein
country: Germany
facility: Migräne and Kopfschmerzklinik Königstein
state: Saksen
city: Kiel
country: Germany
facility: Schmerzklinik und Praxis an der Schmerzklinik Kiel
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Neurologische Klinik und Poliklinik Charité Campus Mitte
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
city: Madrid
country: Spain
facility: Hospital Universitario
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Stockholm
country: Sweden
facility: Karolinska Hospital
state: Stockholms Län
city: Oxford
country: United Kingdom
facility: John Radcliffe hospital
state: Oxfordshire
city: London
country: United Kingdom
facility: Royal London Hospital
state: Royal London Hospital
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
state: Yorkshire
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References: