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Bion for Occipital Nerve Stimulation

Primary Purpose

Chronic Headaches

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
battery-powered bion(R) microstimulator system
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Headaches focused on measuring Chronic headaches, greater occipital nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University College London - Institute of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Demonstrate acceptable rate of adverse events.
The primary efficacy measure is a significant reduction in either headache frequency or severity

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
July 31, 2012
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00205829
Brief Title
Bion for Occipital Nerve Stimulation
Official Title
Bion for Occipital Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headaches
Keywords
Chronic headaches, greater occipital nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Therapy
Arm Type
Experimental
Arm Description
Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device
Intervention Type
Device
Intervention Name(s)
battery-powered bion(R) microstimulator system
Intervention Description
Stimulation on from initial activation and on.
Primary Outcome Measure Information:
Title
Demonstrate acceptable rate of adverse events.
Time Frame
Throughout the Study
Title
The primary efficacy measure is a significant reduction in either headache frequency or severity
Time Frame
4 months Post-Activation Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Goadsby, MD
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London - Institute of Neurology
City
London
ZIP/Postal Code
WC IN 3BG
Country
United Kingdom

12. IPD Sharing Statement

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Bion for Occipital Nerve Stimulation

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