Status:
TERMINATED
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alter...
Eligibility Criteria
Inclusion
- Be diagnosed with multiple migraines per month of moderate to severe intensity;
- Be refractory to medication;
- Be an appropriate candidate for the surgical procedures required fo this study;
- Be willing and able to comply with all study related procedures;
- Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion
- Have onset of headache after age 50;
- Are current substance abusers (including alcohol and illicit drugs);
- Have a significant psychiatric disorder;
- Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
- Have had nerve stimulation for pain relief.
- Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
- Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect.
- Have a condition currently requiring or likely to require the use of MRI or diathermy;
- Have an active implantable device;
- Are pregnant or lactating or planning to become pregnant in the next 14 months;
- Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00747812
Start Date
May 1 2006
End Date
May 1 2012
Last Update
November 27 2020
Active Locations (1)
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1
Royal Free Hospital - Dept of Clinical Neurosciences
London, United Kingdom, NW3 2QG