NCT00205894

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a implantable device, called the bion(R), in the treatment of chronic headache. The bion microstimulator is placed underneath the skin next to the greater occipital nerve. The bion microstimulator then stimulates the nerve by generating small amounts of electrical current.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 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 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 5, 2008

Status Verified

August 1, 2008

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

September 4, 2008

Conditions

Headache Disorders

Keywords

HeadacheChronic headacheMigrainePainCluster headache

Outcome Measures

Primary Outcomes (2)

  • The primary safety measure is the incidence of major complications, defined as device or procedure related major adverse events that require medical and surgical intervention.

  • The primary efficacy measure is a significant reduction in the frequency, severity or duration of the headaches from the preoperative to the three-month follow-up period.

Interventions

bion microstimulatorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be diagnosed with chronic migraine, probable chronic migraine, and/or chronic cluster headache according to the 2004 IHS Classification Criteria (2nd ed.) or be diagnosed with migraine with or without aura
  • Be 18 years of age or older
  • Be willing and able to follow all study-related procedures during the course of the study;
  • Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventative 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 affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade currently in effect;
  • 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 within the next 4 months in a 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; and
  • Currently require, or be likely to require, MRI or diathermy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (1)

  • Trentman TL, Rosenfeld DM, Vargas BB, Schwedt TJ, Zimmerman RS, Dodick DW. Greater occipital nerve stimulation via the Bion microstimulator: implantation technique and stimulation parameters. Clinical trial: NCT00205894. Pain Physician. 2009 May-Jun;12(3):621-8.

    PMID: 19461827DERIVED

MeSH Terms

Conditions

Headache DisordersHeadacheMigraine DisordersPainCluster Headache

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryTrigeminal Autonomic Cephalalgias

Study Officials

  • David Dodick, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2004

Primary Completion

October 1, 2006

Study Completion

September 1, 2007

Last Updated

September 5, 2008

Record last verified: 2008-08

Locations

US(2)