Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2004-06-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active Therapy
Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device
battery-powered bion(R) microstimulator system
Stimulation on from initial activation and on.
Interventions
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battery-powered bion(R) microstimulator system
Stimulation on from initial activation and on.
Eligibility Criteria
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Inclusion Criteria
2. Have headaches characterized by pain
3. Be 18 years of age or older;
4. Be willing and able to follow all study-related procedures during course of study;
5. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.
Exclusion Criteria
2. Have previously undergone destructive ganglionectomy
3. Have had a previous surgery in the intended implant area;
4. Have Arnold-Chiari malformation;
5. Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
6. Be pregnant or planning on becoming pregnant during the study period;
7. Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
8. 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;
9. Currently require, or be likely to require, diathermy;
10. Have other medical conditions that the investigator believes would confound the study.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter J. Goadsby, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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University College London - Institute of Neurology
London, , United Kingdom
Countries
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Other Identifiers
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CR-B-(E)-003
Identifier Type: -
Identifier Source: org_study_id