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Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

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ClinicalTrials.gov Identifier: NCT01184222
Recruitment Status : Unknown
Verified May 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : August 18, 2010
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HEADACHE Device: great occipital nerve stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2010
Actual Primary Completion Date : January 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 Measures :
  1. number of headache days during the 14 days withdrawal period [ Time Frame: 14 days ]
  2. maximal intensity and duration of rebound headache [ Time Frame: 14 days ]
  3. rescue medication used [ Time Frame: 14 days ]
  4. withdrawal facility perceived by the patient [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184222


Contacts
Contact: CAILLON Cynthia giran.c@chu-nice.fr

Locations
France
Neurology department - La timone Not yet recruiting
Marseille, France
Sub-Investigator: DONNET Anne, PhD         
Neurosurvery department Recruiting
Nice, France
Principal Investigator: FONTAINE Denys, PhD         
Principal Investigator: LANTERI-MINET Michel, PhD         
Headache Emergency Center Not yet recruiting
Paris, France
Sub-Investigator: VALADE Dominique, PhD         
Neurology department - CHU Rangueil Not yet recruiting
Toulouse, France
Sub-Investigator: GERAUD Gille, PHD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Chair: FONTAINE Denys, PhD Neurosurgery depatment - CHU Pasteur, Nice
Study Chair: LANTERI-MINET Michet, PhD Neurosurgery department

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01184222     History of Changes
Other Study ID Numbers: 02-API-07
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: May 2010

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms