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Bion for Occipital Nerve Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00205829
First received: September 13, 2005
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chronic Headaches
Device: battery-powered bion(R) microstimulator system
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bion for Occipital Nerve Stimulation

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Demonstrate acceptable rate of adverse events. [ Time Frame: Throughout the Study ] [ Designated as safety issue: Yes ]
  • The primary efficacy measure is a significant reduction in either headache frequency or severity [ Time Frame: 4 months Post-Activation Visit ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2004
Study Completion Date: January 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Stimulation on from initial activation and on.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205829

Locations
United Kingdom
University College London - Institute of Neurology
London, United Kingdom, WC IN 3BG
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Peter J. Goadsby, MD University College London Hospitals
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205829     History of Changes
Other Study ID Numbers: CR-B-(E)-003
Study First Received: September 13, 2005
Last Updated: July 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:
Chronic headaches
greater occipital nerve stimulation

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014