Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

Study Overview
=================
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.

Official 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)

Conditions
-----------------
HEADACHE

Intervention / Treatment
-----------------
* Device: great occipital nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm Active SENGO<br>The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted. | Device: great occipital nerve stimulation<br>* 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.<br>|
| Placebo Comparator: Arm sham SENGO<br>The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted. | Device: great occipital nerve stimulation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |