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bion microstimulator

Phase 1

Headache Disorders | Unknown | Neurology |Boston Scientific Corporation|Last Updated: Sep 5, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

bion microstimulator · 1 trial · 1 indication

Phase 1 1
NCT00205894Occipital Nerve Stimulation to Treat Chronic HeadachesHeadache Disorders
COMPLETED20 Analytics
PHASE1COMPLETED
Occipital Nerve Stimulation to Treat Chronic Headaches
Headache Disorders
NCT0020589420
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Study Endpoints

Primary Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
bion microstimulatorDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. 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 2. Be 18 years of age or older 3. Be willing and able to follow all st...

Countries:United States
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Frequently asked questions about bion microstimulator

What is the Bion microstimulator used for?

The Bion microstimulator is an investigational device being studied for the treatment of headache disorders. It is a microstimulator designed for occipital nerve stimulation, which was evaluated in a Phase 1 clinical trial for chronic headaches. The device is being developed by Boston Scientific Corporation.

Who makes the Bion microstimulator?

Boston Scientific Corporation (NYSE: BSX) is developing the Bion microstimulator. The company conducted a Phase 1 clinical trial of the device for headache disorders. Boston Scientific is a medical device company, and the Bion microstimulator is among its investigational products in the neurology therapeutic area.

What phase is the Bion microstimulator in?

The Bion microstimulator is in Phase 1 clinical development. A Phase 1 trial of the device for headache disorders has been completed. The device is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical development for the treatment of chronic headaches.

What clinical trials is the Bion microstimulator in?

The Bion microstimulator was studied in one clinical trial, NCT00205894, titled 'Occipital Nerve Stimulation to Treat Chronic Headaches.' This Phase 1 trial enrolled 20 participants with headache disorders in the United States. The trial has been completed and was an uncontrolled, non-randomized study.

How does the Bion microstimulator work?

The Bion microstimulator is designed to deliver occipital nerve stimulation, a therapy that involves electrical stimulation of the occipital nerves in the back of the head. This approach was evaluated in a Phase 1 clinical trial for chronic headaches. The device is intended to modulate nerve activity to potentially relieve headache symptoms.