Study of Occipital Nerve Stimulation for Drug Refractory Migraine (PRISM UK)

Boston Scientific

Status and phase: Terminated; Phase 2

Conditions: Migraine

Treatments: Device: Precision

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747812

PRISM-UK-05

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

11 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Device: Precision

2

Sham Comparator group

Description:

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

Treatment:

Device: Precision