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Study of Occipital Nerve Stimulation for Drug Refractory Migraine

NCT ID: NCT00747812

Last Updated: 2020-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Migraine

Keywords

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Headache Migraine Refractory Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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.

Group Type EXPERIMENTAL

Precision

Intervention Type DEVICE

Implantable Neurostimulator

2

Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.

Group Type SHAM_COMPARATOR

Precision

Intervention Type DEVICE

Implantable Neurostimulator

Interventions

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Precision

Implantable Neurostimulator

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J. Goadsby, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

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Royal Free Hospital - Dept of Clinical Neurosciences

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PRISM-UK-05

Identifier Type: -

Identifier Source: org_study_id