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battery-powered bion microstimulator system

Phase 1

Chronic Headaches | Unknown | Pain |Boston Scientific Corporation|Last Updated: Aug 2, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

battery-powered bion microstimulator system · 1 trial · 1 indication

Phase 1 1
NCT00205829Bion for Occipital Nerve StimulationChronic Headaches
COMPLETED10 Analytics
PHASE1COMPLETED
Bion for Occipital Nerve Stimulation
Chronic HeadachesUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active TherapyEXPERIMENTALOccipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device

Interventions

NameTypeDescription
battery-powered bion(R) microstimulator systemDEVICEStimulation on from initial activation and on.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 med...

Countries:United Kingdom
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Frequently asked questions about battery-powered bion microstimulator system

What is the battery-powered bion microstimulator system used for?

The battery-powered bion microstimulator system is used for chronic headaches. It is an investigational device being studied for this condition. The system is designed to deliver stimulation, and it is currently in clinical development for chronic headache treatment.

Who makes the battery-powered bion microstimulator system?

Boston Scientific Corporation (BSX) is developing the battery-powered bion microstimulator system. The company is conducting clinical research on this device for chronic headaches. Boston Scientific is the developer behind this investigational microstimulator system.

What phase is the battery-powered bion microstimulator system in?

The battery-powered bion microstimulator system is in Phase 1 clinical development. It is an investigational device, not yet approved, and is being studied for chronic headaches. The Phase 1 trial has been completed, with the system still in early-stage clinical research.

What clinical trials is the battery-powered bion microstimulator system in?

The battery-powered bion microstimulator system has one completed clinical trial, NCT00205829, titled "Bion for Occipital Nerve Stimulation." This Phase 1 study enrolled 10 participants with chronic headaches in the United Kingdom. The trial was uncontrolled and not randomized or double-blinded.

Is the battery-powered bion microstimulator system the same as the Bion?

The battery-powered bion microstimulator system is referred to as the Bion in clinical trial records. The study NCT00205829 is titled "Bion for Occipital Nerve Stimulation," indicating the system is also known as the Bion. Both names refer to the same investigational device.