Study of Occipital Nerve Stimulation for Drug Refractory Migraine

Migraine Clinical Trial

— PRISM UK  

Official title:

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00747812
• Other study ID #: PRISM-UK-05
• Status: Terminated
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: May 2012

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2012
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Precision
Implantable Neurostimulator

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital - Dept of Clinical Neurosciences	London

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hours of Headache		12 weeks
Primary	Number of Days With 4 or More Hours of Headache		12 Weeks