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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02227758
Date of registration:	16/04/2014
Prospective Registration:	No
Primary sponsor:	Abbott Medical Devices
Public title:	Peripheral Nerve Stimulation Registry for Intractable Migraine Headache Relief
Scientific title:	Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
Date of first enrolment:	September 2012
Target sample size:	112
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02227758
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Belgium	Germany	Luxembourg	Netherlands	Spain	Sweden	United Kingdom

Contacts

Key inclusion & 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intractable Chronic Migraine

Intervention(s)

Primary Outcome(s)

Physician Satisfaction [Time Frame: 3 months]

Adverse Events (First 12 Weeks) [Time Frame: 3 months]

Quality of Life [Time Frame: 3 months]

Headache Days [Time Frame: 3 months]

Patient Satisfaction [Time Frame: 3 months]

Headache Pain Relief [Time Frame: 3 months]

Migraine Disability [Time Frame: 3 months]

Secondary Outcome(s)

Secondary ID(s)

NM-11-059-EU-ON

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	31/12/2018
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02227758

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