Bion for Occipital Nerve Stimulation

Chronic Headaches Clinical Trial

Official title:

Bion for Occipital Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205829
• Other study ID #: CR-B-(E)-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: July 31, 2012
• Start date: June 2004
• Est. completion date: January 2009

Study information

• Verified date: July 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be diagnosed with chronic migraine or primary chronic daily headache

2. Have headaches characterized by pain

3. Be 18 years of age or older;

4. Be willing and able to follow all study-related procedures during course of study;

5. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.

Exclusion Criteria:

1. Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;

2. Have previously undergone destructive ganglionectomy

3. Have had a previous surgery in the intended implant area;

4. Have Arnold-Chiari malformation;

5. Have participated within the last 30 days or plan to participate during this study in another device or drug trial;

6. Be pregnant or planning on becoming pregnant during the study period;

7. Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;

8. 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;

9. Currently require, or be likely to require, diathermy;

10. Have other medical conditions that the investigator believes would confound the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headaches

Intervention

Device:
• battery-powered bion(R) microstimulator system
Stimulation on from initial activation and on.

Locations

Country	Name	City	State
United Kingdom	University College London - Institute of Neurology	London

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate acceptable rate of adverse events.		Throughout the Study	Yes
Primary	The primary efficacy measure is a significant reduction in either headache frequency or severity		4 months Post-Activation Visit	No