Study of Occipital Nerve Stimulation for Drug Refractory Migraine

Phase 2

Terminated

• Conditions: Migraine
• Interventions: Device: Precision

• Registration Number: NCT00747812
• Lead Sponsor: Boston Scientific Corporation

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 alternative therapies are needed.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2008-11
• Study Completion: 2012-05
• Results First Submitted: 2012-06-28
• Results First Submitted QC: 2012-06-28
• Results First Posted: 2012-08-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Precision	Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
2	Precision	Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.

Primary Outcome Measures

Name	Time	Method
Number of Days With 4 or More Hours of Headache	12 Weeks
Number of Hours of Headache	12 weeks

Trial Locations

Locations (1)

Royal Free Hospital - Dept of Clinical Neurosciences; 🇬🇧 London, United Kingdom