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NCT01184222 Clinical Trial

Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

HEADACHE Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01184222
Other study ID # 02-API-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date December 2012

Study information
Verified date March 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• great 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.

Locations
Country Name City State
France Neurology department - La timone Marseille
France Neurosurvery department Nice
France Headache Emergency Center Paris
France Neurology department - CHU Rangueil Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 number of headache days during the 14 days withdrawal period 14 days
Secondary maximal intensity and duration of rebound headache 14 days
Secondary rescue medication used 14 days
Secondary withdrawal facility perceived by the patient 14 days
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