Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: HEADACHE

Treatments: Device: great occipital nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01184222

02-API-07

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Arm Active SENGO

Active Comparator group

Description:

The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.

Treatment:

Device: great occipital nerve stimulation

Arm sham SENGO

Placebo Comparator group

Description:

The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Treatment:

Device: great occipital nerve stimulation