Bion for Occipital Nerve Stimulation - Full Text View

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 I Phase II

MedlinePlus related topics:

Headache

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Bion for Occipital Nerve Stimulation

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
Estimated Study Completion Date:	December 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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.

Contacts and Locations

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

Responsible Party:	Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager )
Study ID Numbers:	CR-B-(E)-003
First Received:	September 13, 2005
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00205829
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:

Chronic headaches

greater occipital nerve stimulation

Study placed in the following topic categories:

Signs and Symptoms

Headache

Central Nervous System Diseases

Neurologic Manifestations

Pain

Brain Diseases

Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00205829