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Bion for Occipital Nerve Stimulation

NCT00205829 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-08-02

No results posted yet for this study

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.

Conditions

  • Chronic Headaches

Interventions

DEVICE

battery-powered bion(R) microstimulator system

Stimulation on from initial activation and on.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Peter J. Goadsby, MD · University College London Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-08-31
Completion
2009-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00205829 on ClinicalTrials.gov