Peripheral Nerve Stimulation Registry for Intractable Migraine Headache (Relief)

Abbott

Status: Completed

Conditions: Intractable Chronic Migraine

Study type: Observational

Funder types: Industry

Identifiers

NCT02227758

NM-11-059-EU-ON

Details and patient eligibility

About

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

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

112 participants in 1 patient group

implanted chronic migraine patients

Description:

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