Chronic, Medically Refractory HeadacheNCT01050959
Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study
An observational study of Chronic, Medically Refractory Headache, run by Boston Scientific Corporation at 2 sites in United States.
Trial summary
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic, Medically Refractory Headache
- What is being tested?
- bion
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Apr 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.
Who may be able to join
- Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
- Subject elects to enroll in this compassionate use study and provides written informed consent.
- Subject understands the type and duration of clinical, technical or product support provided in the study.
- Subject is willing to comply with protocol-required activities.
Who cannot join
- Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
About this study
Official title: Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
- Conditions
- Chronic, Medically Refractory Headache
- Being tested
- bion
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of one year of clinical and technical support
This is a compassionate use study. There are no primary outcome measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic, Medically Refractory HeadacheStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study chair, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050959
- Sponsor's protocol ID
- A4005
- Other IDs
- G030225/S022
- Status last verified
- Nov 2013
- First submitted
- 14 Jan 2010
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
- ClinicalTrials.gov ID
- NCT01050959
- Acronym / sponsor ID
- A4005
- Conditions
- Chronic, Medically Refractory Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Jan 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.
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.
Key inclusion criteria (4 listed)
- Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
- Subject elects to enroll in this compassionate use study and provides written informed consent.
- Subject understands the type and duration of clinical, technical or product support provided in the study.
- Subject is willing to comply with protocol-required activities.
Key exclusion criteria (1 listed)
- Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches 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 |
|---|---|---|
| bion | Device | – |
Primary outcome
Provision of one year of clinical and technical support
This is a compassionate use study. There are no primary outcome measures.
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 13 Nov 2020.
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.
Roshini Jain study chair
Boston Scientific Neuromodulation Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic, Medically Refractory Headache, run by Boston Scientific Corporation at 2 sites in United States.
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 1 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Provision of one year of clinical and technical support. 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 13 Nov 2020.