HEADACHENCT01184222
Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache
A study testing great occipital nerve stimulation in people with HEADACHE, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEADACHE
- What is being tested?
- great occipital nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Neurology department - La timone
Marseille
Neurosurvery department
Nice
Headache Emergency Center
Paris
Neurology department - CHU Rangueil
Toulouse
About this study
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)
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.
- Conditions
- HEADACHE
- Being tested
- great occipital nerve stimulation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
great occipital nerve stimulationDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm Active SENGO | Active comparator | The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted. Receives: Device: great occipital nerve stimulation |
| Arm sham SENGO | Placebo comparator | The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted. Receives: Device: great occipital nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)
Measured: 14 days
Secondary outcomes (4)
number of headache days during the 14 days withdrawal period
Measured: 14 days
maximal intensity and duration of rebound headache
Measured: 14 days
rescue medication used
Measured: 14 days
withdrawal facility perceived by the patient
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEADACHEStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FONTAINE Denys, PhD, Study chair, Neurosurgery depatment - CHU Pasteur, NiceLANTERI-MINET Michet, PhD, Study chair, Neurosurgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184222
- Sponsor's protocol ID
- 02-API-07
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2010
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01184222
- Acronym / sponsor ID
- 02-API-07
- Conditions
- HEADACHE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Active SENGO | Active comparator | Device: great occipital nerve stimulationThe patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted. |
| Arm sham SENGO | Placebo comparator | Device: great occipital nerve stimulationThe patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm Active SENGO, Arm sham SENGO |
Primary outcome
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
4 secondary outcomes
number of headache days during the 14 days withdrawal period
Time frame: 14 days
maximal intensity and duration of rebound headache
Time frame: 14 days
rescue medication used
Time frame: 14 days
withdrawal facility perceived by the patient
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FONTAINE Denys, PhD study chair
Neurosurgery depatment - CHU Pasteur, Nice
LANTERI-MINET Michet, PhD study chair
Neurosurgery department
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing great occipital nerve stimulation in people with HEADACHE, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.