Bion for Occipital Nerve Stimulation

Boston Scientific

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Headaches

Treatments: Device: battery-powered bion(R) microstimulator system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00205829

CR-B-(E)-003

Details and patient eligibility

About

This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be diagnosed with chronic migraine or primary chronic daily headache
2. Have headaches characterized by pain
3. Be 18 years of age or older;
4. Be willing and able to follow all study-related procedures during course of study;
5. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.

Exclusion criteria

1. Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
2. Have previously undergone destructive ganglionectomy
3. Have had a previous surgery in the intended implant area;
4. Have Arnold-Chiari malformation;
5. Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
6. Be pregnant or planning on becoming pregnant during the study period;
7. Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
8. Demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study;
9. Currently require, or be likely to require, diathermy;
10. Have other medical conditions that the investigator believes would confound the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Active Therapy

Experimental group

Description:

Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device

Treatment:

Device: battery-powered bion(R) microstimulator system