NCT00205829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

University College London - Institute of Neurology

London, WC IN 3BG, United Kingdom

Location

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

Study Design

Study Type
interventional
Phase
phase 1
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 1, 2004

Primary Completion

August 1, 2007

Study Completion

January 1, 2009

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

GB(1)