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Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

Primary Purpose

HEADACHE

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
great occipital nerve stimulation
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HEADACHE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurology department - La timone
  • Neurosurvery departmentRecruiting
  • Headache Emergency Center
  • Neurology department - CHU Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Active SENGO

Arm sham SENGO

Arm Description

The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.

The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Outcomes

Primary Outcome Measures

Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2010
Last Updated
February 20, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01184222
Brief Title
Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HEADACHE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm Active SENGO
Arm Type
Active Comparator
Arm Description
The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
Arm Title
Arm sham SENGO
Arm Type
Placebo Comparator
Arm Description
The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.
Intervention Type
Device
Intervention Name(s)
great occipital nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
number of headache days during the 14 days withdrawal period
Time Frame
14 days
Title
maximal intensity and duration of rebound headache
Time Frame
14 days
Title
rescue medication used
Time Frame
14 days
Title
withdrawal facility perceived by the patient
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CAILLON Cynthia
Email
giran.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FONTAINE Denys, PhD
Organizational Affiliation
Neurosurgery depatment - CHU Pasteur, Nice
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
LANTERI-MINET Michet, PhD
Organizational Affiliation
Neurosurgery department
Official's Role
Study Chair
Facility Information:
Facility Name
Neurology department - La timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DONNET Anne, PhD
Facility Name
Neurosurvery department
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FONTAINE Denys, PhD
First Name & Middle Initial & Last Name & Degree
LANTERI-MINET Michel, PhD
Facility Name
Headache Emergency Center
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VALADE Dominique, PhD
Facility Name
Neurology department - CHU Rangueil
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GERAUD Gille, PHD

12. IPD Sharing Statement

Learn more about this trial

Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

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