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Completed

NCT Number: NCT01184222

Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.

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Key information

Conditions

Headache 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

Neurology department - La timone, Marseille, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age > 18 years old
  • migraine patient with medication overuse headache by non specific analgesics according to the ICHD-II diagnostic criteria
  • failure of outpatient withdrawal
  • Signature of informed consent.
  • Affiliation to French national health and pensions organization

Exclusion criteria

  • pregnancy (positive pregnancy test at pre-study) and breast-feeding
  • patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ICHD-II diagnostic criteria
  • previous surgical treatment targeting great occipital nerves

Treatment and study plan

great occipital nerve stimulation

Device
  • Active Comparator: Arm Active SENGO The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
  • Arm sham SENGO : The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Primary outcomes

  1. Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)

    Time frame: 14 days

Secondary outcomes

  1. number of headache days during the 14 days withdrawal period

    Time frame: 14 days

  2. maximal intensity and duration of rebound headache

    Time frame: 14 days

  3. rescue medication used

    Time frame: 14 days

  4. withdrawal facility perceived by the patient

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 18, 2010
Registry last updated
Mar 18, 2024

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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