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Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01184222
First received: July 19, 2010
Last updated: February 20, 2012
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
HEADACHE
 Device: great occipital nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

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) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of headache days during the 14 days withdrawal period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • maximal intensity and duration of rebound headache [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • rescue medication used [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • withdrawal facility perceived by the patient [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01184222     History of Changes
Other Study ID Numbers: 02-API-07
Study First Received: July 19, 2010
Last Updated: February 20, 2012
Health Authority: France: French Data Protection Authority
France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on May 19, 2013