- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205829
Bion for Occipital Nerve Stimulation
July 31, 2012 updated by: Boston Scientific Corporation
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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London, United Kingdom, WC IN 3BG
- University College London - Institute of Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Therapy
Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device
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Stimulation on from initial activation and on.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstrate acceptable rate of adverse events.
Time Frame: Throughout the Study
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Throughout the Study
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The primary efficacy measure is a significant reduction in either headache frequency or severity
Time Frame: 4 months Post-Activation Visit
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4 months Post-Activation Visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter J. Goadsby, MD, University College London Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
July 31, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-B-(E)-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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