Peripheral Nerve Stimulation Registry for Intractable Migraine Headache (Relief)

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

Study Overview

• Status: Completed
• Conditions: Intractable Chronic Migraine

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Centre Hospitalier Régional de la Citadelle
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Heilig Hartziekenhuis
• Germany
  • Berlin, Germany, 10117
    • Neurologische Klinik und Poliklinik Charité Campus Mitte
  • Großherzogtum Oldenburg
    • Delmenhorst, Großherzogtum Oldenburg, Germany, 27753
      • Klinikum Delmenhorst GmbH
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 81377
      • Universitätsklinikum Düsseldorf
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
    • Essen, Nordrhein-Westfalen, Germany, 45133
      • Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie
  • Saksen
    • Königstein, Saksen, Germany, 61462
      • Migräne and Kopfschmerzklinik Königstein
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24129
      • Schmerzklinik und Praxis an der Schmerzklinik Kiel
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg
• Spain
  • Madrid, Spain, 28222
    • Hospital Puerta de Hierro
  • Madrid, Spain, 28046
    • Hospital Universitario
  • Andalucia
    • Sevilla, Andalucia, Spain, 41013
      • Hospital Universitario Virgen del Rocío
• Sweden
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden, 17176
      • Karolinska Hospital
• United Kingdom
  • London, United Kingdom, sE5 9NT
    • King's College Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX39DU
      • John Radcliffe Hospital
  • Royal London Hospital
    • London, Royal London Hospital, United Kingdom, E1 1BB
      • Royal London Hospital
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS146UH
      • Seacroft Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: NM-11-059-EU-ON