Status:
COMPLETED
Bion for Occipital Nerve Stimulation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Headaches
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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. The clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00205829
Start Date
June 1 2004
End Date
January 1 2009
Last Update
August 2 2012
Active Locations (1)
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1
University College London - Institute of Neurology
London, United Kingdom, WC IN 3BG