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Completed

NCT Number: NCT00407992

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

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

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Sacro Cuore - Don Calabria

Negrar, Verona, 37024, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occipital nerve stimulation ON

Device

Implant of an occipital nerve stimulator switched ON

Occipital nerve stimulation off

Device

Implant of an occipital nerve stimulator switched OFF

Primary outcomes

  1. Number and the type of adverse events

    Time frame: Study period

  2. Reduction of headache frequency and intensity

    Time frame: Study period

Secondary outcomes

  1. Reduction in drug intake

    Time frame: Study period

  2. Changes in QoL and interference in everyday activities

    Time frame: Study period

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

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

Acronym: Migraine

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2006
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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