Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

Not Applicable

Completed

• Conditions: HEADACHE
• Interventions: Device: great occipital nerve stimulation

• Registration Number: NCT01184222
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Study Start: 2010-11
• Primary Completion: 2011-01
• Study Completion: 2012-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm Active SENGO	great occipital nerve stimulation	The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
Arm sham SENGO	great occipital nerve stimulation	The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Neurology department - CHU Rangueil; 🇫🇷 Toulouse, France

Neurology department - La timone; 🇫🇷 Marseille, France

Headache Emergency Center; 🇫🇷 Paris, France

Neurosurvery department; 🇫🇷 Nice, France