Chronic Migraine HeadachePhase 1ONSTIMNCT00200109
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
A Phase 1 study testing Occipital Nerve Stimulation in people with Chronic Migraine Headache, run by MedtronicNeuro at 9 sites in 3 countries.
Trial summary
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- Occipital Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 9 sitesin 3 countries
- Study dates
- May 2004to May 2011
- Phase
- Phase 1
- 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
- Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
- compliance with daily questionnaire
- headache that has not responded to at least two classes of headache medications
- stable headache medication regimen
Who cannot join
- previous surgical procedures to disrupt the nerves of the neck relating to the headache
- subjects who may require MRI or Diathermy
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Contact Medtronic for Exact Locations
Ann Arbor, Michigan, 48104
Contact Medtronic for Exact Locations
Denver, Colorado, 80045
Contact Medtronic for Exact Locations
Detroit, Michigan, 48202
Contact Medtronic for Exact Locations
Oceanside, California, 92024
Contact Medtronic for Exact Locations
Oklahoma City, Oklahoma, 73152
Contact Medtronic for Exact Locations
Philadelphia, Pennsylvania, 19107
Contact Medtronic for Exact Location
Scottsdale, Arizona, 85054
About this study
Official title: ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.
Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.
Read the detailed description
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.
- Conditions
- Chronic Migraine Headache
- Being tested
- Occipital Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital Nerve StimulationDevice
Each group had a different plan
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | See protocol Receives: Device: Occipital Nerve Stimulation |
| Group 2 | Other | See protocol Receives: Device: Occipital Nerve Stimulation |
| Group 3 | Other | See protocol Receives: Device: Occipital Nerve Stimulation |
| Group 4 | Other | See protocol Receives: Device: Occipital Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A primary endpoint is not identified for this feasibility study.
Measured: No primary endpoint
Secondary outcomes (1)
Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.
Measured: No secondary endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2008
- Study completionMay 2011
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 Chronic Migraine HeadacheStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Saper, M.D., Principal investigator, Michigan Head Pain and Neurological Institute, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200109
- Sponsor's protocol ID
- 1602
- Acronym
- ONSTIM
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2005
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.
PubMed 20861241
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
- ClinicalTrials.gov ID
- NCT00200109
- Acronym / sponsor ID
- ONSTIM / 1602
- Conditions
- Chronic Migraine Headache
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Sep 2005 (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.
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.
Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.
Detailed description
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: Occipital Nerve StimulationSee protocol |
| Group 2 | Other | Device: Occipital Nerve StimulationSee protocol |
| Group 3 | Other | Device: Occipital Nerve StimulationSee protocol |
| Group 4 | Other | Device: Occipital Nerve StimulationSee protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
- compliance with daily questionnaire
- headache that has not responded to at least two classes of headache medications
- stable headache medication regimen
Key exclusion criteria (2 listed)
- previous surgical procedures to disrupt the nerves of the neck relating to the headache
- subjects who may require MRI or Diathermy
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 StimulationEach group had a different plan | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
A primary endpoint is not identified for this feasibility study.
Time frame: No primary endpoint
1 secondary outcome
Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.
Time frame: No secondary endpoint
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 12 Oct 2011.
- Results publication: PubMed 20861241Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.
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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.
Joel Saper, M.D. principal investigator
Michigan Head Pain and Neurological Institute, Ann Arbor, MI
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Occipital Nerve Stimulation in people with Chronic Migraine Headache, run by MedtronicNeuro at 9 sites in 3 countries.
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 4 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A primary endpoint is not identified for this feasibility study. (time frame: No primary endpoint). 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 NCT00200109, 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 12 Oct 2011.