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OpenTrials
Completed

NCT Number: NCT02227758

Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

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

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Key information

Conditions

Intractable Chronic Migraine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heilig Hartziekenhuis, Roeselare, West-Vlaanderen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Adverse Events (First 12 Weeks)

    Time frame: 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.

  2. Headache Pain Relief

    Time frame: 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)

  3. Headache Days

    Time frame: 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.

  4. Migraine Disability

    Time frame: 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.

  5. Patient Satisfaction

    Time frame: 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)

  6. Physician Satisfaction

    Time frame: 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)

  7. Quality of Life

    Time frame: 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)

  8. Quality of Life

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: Relief

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2014
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.