An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Completed

Conditions: Headache, Migraine

Treatments: Device: Occipital nerve stimulation ON; Device: Occipital nerve stimulation off

Study type: Interventional

Funder types: Other

Identifiers

NCT00407992

MFGGL113006

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with migraine
• patients 18 years aged or above

Exclusion criteria

• patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
• patients pregnant or planning on becoming pregnant during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Occipital nerve stimulation ON

Experimental group

Treatment:

Device: Occipital nerve stimulation ON

Occipital nerve stimulation OFF

Other group

Treatment:

Device: Occipital nerve stimulation off