Status:
COMPLETED
Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
Lead Sponsor:
Abbott Medical Devices
Conditions:
Intractable Chronic Migraine
Eligibility:
All Genders
18+ years
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 pro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT02227758
Start Date
September 1 2012
End Date
December 1 2015
Last Update
February 4 2019
Active Locations (18)
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1
Heilig Hartziekenhuis
Roeselare, West-Vlaanderen, Belgium, 8800
2
Centre Hospitalier Régional de la CITADELLE
Liège, Belgium, 4000
3
Klinikum Delmenhorst GmbH
Delmenhorst, Großherzogtum Oldenburg, Germany, 27753
4
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 81377