Chronic HeadachesPhase 1/2NCT00205829
Bion for Occipital Nerve Stimulation
A Phase 1/2 study testing battery-powered bion(R) microstimulator system in people with Chronic Headaches, run by Boston Scientific Corporation at 1 site in United Kingdom.
Trial summary
This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Headaches
- What is being tested?
- battery-powered bion(R) microstimulator system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2004to Jan 2009
- Phase
- Phase 1/2
- 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
- Be diagnosed with chronic migraine or primary chronic daily headache
- Have headaches characterized by pain
- Be 18 years of age or older;
- Be willing and able to follow all study-related procedures during course of study;
- Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.
Who cannot join
- Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
- Have previously undergone destructive ganglionectomy
- Have had a previous surgery in the intended implant area;
- Have Arnold-Chiari malformation;
- Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
- Be pregnant or planning on becoming pregnant during the study period;
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- Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
- Demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study;
- Currently require, or be likely to require, diathermy;
- Have other medical conditions that the investigator believes would confound the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London - Institute of Neurology
London, WC IN 3BG
About this study
This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.
- Conditions
- Chronic Headaches
- Being tested
- battery-powered bion(R) microstimulator system
- Keywords
- Chronic headaches, greater occipital nerve stimulation
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
battery-powered bion(R) microstimulator systemDevice
Stimulation on from initial activation and on.
| Study group | Role | What they receive |
|---|---|---|
| Active Therapy | Experimental | Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device Receives: Device: battery-powered bion(R) microstimulator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate acceptable rate of adverse events.
Measured: Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
Measured: 4 months Post-Activation Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadachesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J. Goadsby, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205829
- Sponsor's protocol ID
- CR-B-(E)-003
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bion for Occipital Nerve Stimulation
- ClinicalTrials.gov ID
- NCT00205829
- Acronym / sponsor ID
- CR-B-(E)-003
- Conditions
- Chronic Headaches
- Keywords
- Chronic headaches, greater occipital nerve stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 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.
This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Therapy | Experimental | Device: battery-powered bion(R) microstimulator systemOccipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be diagnosed with chronic migraine or primary chronic daily headache
- Have headaches characterized by pain
- Be 18 years of age or older;
- Be willing and able to follow all study-related procedures during course of study;
- Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.
Key exclusion criteria (10 listed)
- Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
- Have previously undergone destructive ganglionectomy
- Have had a previous surgery in the intended implant area;
- Have Arnold-Chiari malformation;
- Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
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 |
|---|---|---|
| battery-powered bion(R) microstimulator systemStimulation on from initial activation and on. | Device | Active Therapy |
Primary outcome
Demonstrate acceptable rate of adverse events.
Time frame: Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
Time frame: 4 months Post-Activation Visit
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 2 Aug 2012.
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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.
Peter J. Goadsby, MD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing battery-powered bion(R) microstimulator system in people with Chronic Headaches, run by Boston Scientific Corporation at 1 site in United Kingdom.
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 10 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 2 Aug 2012. 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 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Demonstrate acceptable rate of adverse events. (time frame: Throughout the Study). 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?
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 2 Aug 2012.