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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407992

Acronym

Migraine

Enrollment

Registered

2006-12-05

Start date

2006-12-31

Completion date

2010-12-31

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

Keywords

Headache, Migraine

Brief summary

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

Interventions

DEVICEOccipital nerve stimulation ON

Implant of an occipital nerve stimulator switched ON

DEVICEOccipital nerve stimulation off

Implant of an occipital nerve stimulator switched OFF

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number and the type of adverse events	Study period
Reduction of headache frequency and intensity	Study period

Secondary

Measure	Time frame
Reduction in drug intake	Study period
Changes in QoL and interference in everyday activities	Study period

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026