NCT00205829

CompletedPhase 1/2

Bion for Occipital Nerve Stimulation

Boston Scientific Corporation Source

Compare

Other study identifiers

Sponsor study identifier

CR-B-(E)-003

Study Type

interventional

Actual enrollment (reported)

10

Locations

1 country

Sites

1

Timeline

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2007

Actual (reported)

Study Completion

January 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: January 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Primary Completion
August 2007
Actual (reported)
Study Completion
January 2009
Actual (reported)

Last Updated: August 2, 2012
Status Verified: July 2012
Last Update Submitted: July 31, 2012

Conditions

Chronic Headaches

Keywords

Chronic headachesgreater occipital nerve stimulation

Outcome Measures

Primary Outcomes (2)

Demonstrate acceptable rate of adverse events.
Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
4 months Post-Activation Visit

Study Arms (1)

Active Therapy

EXPERIMENTAL

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

Device: battery-powered bion(R) microstimulator system

Interventions

battery-powered bion(R) microstimulator systemDevice

Stimulation on from initial activation and on.

Active Therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be diagnosed with chronic migraine or primary chronic daily headache
Have headaches characterized by pain

Sponsors & Collaborators

Boston Scientific Corporation
Industrylead

Study Sites (1)

University College London - Institute of Neurology

London, WC IN 3BG, United Kingdom

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

Peter J. Goadsby, MD
University College London Hospitals
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

NCT02302027

Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache

Not ApplicableUnknown

NCT03503734

Integrated Care for Migraine and Chronic Tension-type Headaches

Completed

NCT05414513

The Turkish Fear of Pain Questionnaire

Unknown

NCT00897780

Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache

Not ApplicableUnknown

NCT02684916

Chiropractic Treatment for Headache Among Children Aged 7-14

Not ApplicableCompleted

NCT00286923

Does Topiramate Adjust the Excitability of the Brain in Migraine Sufferers?

Unknown

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

August 2007

Actual (reported)

Study Completion

January 2009

Actual (reported)

Last Updated

August 2, 2012

Record last verified: 2012-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00205829
Data provider: ClinicalTrials.gov
Source updated: 2012-08-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:43 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Active Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations