Headache, MigraineMigraineNCT00407992
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
A study testing Occipital nerve stimulation ON and Occipital nerve stimulation off in people with Headache, Migraine, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Occipital nerve stimulation ON and Occipital nerve stimulation off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to Dec 2010
- 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
- patients with migraine
- patients 18 years aged or above
Who cannot join
- patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
- patients pregnant or planning on becoming pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache
- Conditions
- Headache, Migraine
- Being tested
- Occipital nerve stimulation ON, Occipital nerve stimulation off
- Keywords
- Headache, Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital nerve stimulation ONDevice
Implant of an occipital nerve stimulator switched ON
Occipital nerve stimulation offDevice
Implant of an occipital nerve stimulator switched OFF
| Study group | Role | What they receive |
|---|---|---|
| Occipital nerve stimulation ON | Experimental | Not described Receives: Device: Occipital nerve stimulation ON |
| Occipital nerve stimulation OFF | Other | Not described Receives: Device: Occipital nerve stimulation off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and the type of adverse events
Measured: Study period
Reduction of headache frequency and intensity
Measured: Study period
Secondary outcomes (2)
Reduction in drug intake
Measured: Study period
Changes in QoL and interference in everyday activities
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Serra, Principal investigator, IRCCS Sacro Cuore Don Calabria di Negrar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407992
- Sponsor's protocol ID
- MFGGL113006
- Acronym
- Migraine
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2006
- Last updated
- 23 Sep 2019
- Results posted
- No
Publications
Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.
PubMed 22622909
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
- ClinicalTrials.gov ID
- NCT00407992
- Acronym / sponsor ID
- Migraine / MFGGL113006
- Conditions
- Headache, Migraine
- Keywords
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Dec 2006 (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.
The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occipital nerve stimulation ON | Experimental | Device: Occipital nerve stimulation ON |
| Occipital nerve stimulation OFF | Other | Device: Occipital nerve stimulation off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with migraine
- patients 18 years aged or above
Key exclusion criteria (2 listed)
- patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
- patients pregnant or planning on becoming pregnant during the study period
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 |
|---|---|---|
| Occipital nerve stimulation ONImplant of an occipital nerve stimulator switched ON | Device | Occipital nerve stimulation ON |
| Occipital nerve stimulation offImplant of an occipital nerve stimulator switched OFF | Device | Occipital nerve stimulation OFF |
Primary outcome
Number and the type of adverse events
Time frame: Study period
Reduction of headache frequency and intensity
Time frame: Study period
2 secondary outcomes
Reduction in drug intake
Time frame: Study period
Changes in QoL and interference in everyday activities
Time frame: Study period
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 23 Sep 2019.
- Results publication: PubMed 22622909Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.
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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.
Gerardo Serra principal investigator
IRCCS Sacro Cuore Don Calabria di Negrar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital nerve stimulation ON and Occipital nerve stimulation off in people with Headache, Migraine, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 2 inclusion and 2 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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?
Number and the type of adverse events (time frame: Study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407992, which also lists 1 linked publication.
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 23 Sep 2019.