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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01184222 |
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Date of registration:
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19/07/2010 |
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Primary sponsor: |
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Public title:
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Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache
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Scientific title:
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EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study) |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01184222 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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CAILLON Cynthia |
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Address:
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Telephone:
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Email:
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giran.c@chu-nice.fr |
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Affiliation:
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Name:
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LANTERI-MINET Michet, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurosurgery department |
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Name:
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FONTAINE Denys, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurosurgery depatment - CHU Pasteur, Nice |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HEADACHE
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Intervention(s)
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Device: great occipital nerve stimulation
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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maximal intensity and duration of rebound headache
[Time Frame: 14 days]
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number of headache days during the 14 days withdrawal period
[Time Frame: 14 days]
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rescue medication used
[Time Frame: 14 days]
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withdrawal facility perceived by the patient
[Time Frame: 14 days]
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Secondary ID(s)
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02-API-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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