Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

March 15, 2024 updated by: Centre Hospitalier Universitaire de Nice

EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Neurology department - La timone
      • Nice, France
        • Neurosurvery department
      • Paris, France
        • Headache Emergency Center
      • Toulouse, France
        • Neurology department - CHU Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm Active SENGO
The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
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.
Placebo Comparator: Arm sham SENGO
The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
number of headache days during the 14 days withdrawal period
Time Frame: 14 days
14 days
maximal intensity and duration of rebound headache
Time Frame: 14 days
14 days
rescue medication used
Time Frame: 14 days
14 days
withdrawal facility perceived by the patient
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Chair: FONTAINE Denys, PhD, Neurosurgery depatment - CHU Pasteur, Nice
  • Study Chair: LANTERI-MINET Michet, PhD, Neurosurgery department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimated)

August 18, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-API-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HEADACHE

Clinical Trials on great occipital nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe