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Completed

NCT Number: NCT00205829

Bion for Occipital Nerve Stimulation

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.

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Key information

Conditions

Chronic Headaches Brain Diseases Central Nervous System Diseases Headache Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University College London - Institute of Neurology

London, WC IN 3BG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
  • Have previously undergone destructive ganglionectomy
  • Have had a previous surgery in the intended implant area;
  • Have Arnold-Chiari malformation;
  • Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
  • Be pregnant or planning on becoming pregnant during the study period;
  • Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
  • 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;
  • Currently require, or be likely to require, diathermy;
  • Have other medical conditions that the investigator believes would confound the study.

Treatment and study plan

battery-powered bion(R) microstimulator system

Device

Stimulation on from initial activation and on.

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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