HEADACHE
Conditions
Brief summary
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.
Interventions
DEVICEgreat occipital nerve stimulation
* 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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham) | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| number of headache days during the 14 days withdrawal period | 14 days |
| maximal intensity and duration of rebound headache | 14 days |
| rescue medication used | 14 days |
| withdrawal facility perceived by the patient | 14 days |
Countries
France
Outcome results
None listed