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CompletedNCT00205829Updated Aug 2, 2012

Bion for Occipital Nerve Stimulation

A Phase 1/2 interventional study of battery-powered bion(R) microstimulator system in Chronic Headaches, sponsored by Boston Scientific Corporation. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by Boston Scientific Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Headaches

Keywords

  • Chronic headaches
  • greater occipital nerve stimulation
03

In context

Headache Disorders

162 studies on the registry are indexed under Headache Disorders; 40 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 103 interventional studies indexed under Headache Disorders.

Browse Headache Disorders studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Active Therapy

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

    Device: battery-powered bion(R) microstimulator system

Interventions

  • Devicebattery-powered bion(R) microstimulator system

    Stimulation on from initial activation and on.

06

What researchers measure

Primary outcomes

  1. Demonstrate acceptable rate of adverse events.

    Time frame: Throughout the Study

  2. The primary efficacy measure is a significant reduction in either headache frequency or severity

    Time frame: 4 months Post-Activation Visit

07

Study locations

1 site
  • University College London - Institute of Neurology
    London, WC IN 3BG, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00205829
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Jun 2004
Primary completion
Aug 2007
Completion
Jan 2009
Last update
Aug 2, 2012

Study contacts

Peter J. Goadsby, MD
principal investigator · University College London Hospitals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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