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malexander

multi-directional leads

6 posts in this topic

I understand that there is a new multi-directional lead that has been developed for DBS.  I also understand that it has shown soon advantages over unidirectional leads.  Is this device available in the US?  Are there also disadvantages that should be considered?

 

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The device that is able to modulate DBS electricity in different regions is made by Boston Scientific.  There have been some interesting small studies in Europe.  The device is now in trial in the US.  Data is accumulating.  There are also many other devices in various stages of development.  It is an interesting time in DBS therapy.  Some devices may in the near future be able to steer in specific directions in brain space!

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I was not referring to the device made by Boston Scientific, but rather one made by Aleva Neurotherapeutics.  Their web site claims their device nearly eliminates complications and side effects of the DBS procedure.  A study from the journal "Brain" supposedly reports a 41% wider "therapeutic window" with this multidirectional device.

 

If this--or other--new devices hold significant promise, would it be reasonable for DBS candidates to postpone their surgeries until the next generation of devices are available?

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This is the reference for the article.  It was a very small study on a very new device that is not ready for prime time.  Many companies are interested and developing similar products.  It will need much more rigorous testing, but may indeed be helpful for some patients.  In general, existing technology has proven excellent and we don't recommend waiting for these leads at this time.  They will however help some patients when available.

 

Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schüpbach M - Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain 2014; doi:10.1093/brain/awu102. 

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May I add some clarification to the question, so as to correct some misleading marketing misuse of the term "directional" in the promotional releases to investors.

- the current DBS technology by Medtronic has 4 electrical sources space linearly on the lead; some degree of variation among the inputs allows tailoring of the stimulation field in the longitudinal direction along the lead, but in the circumferential direction the field is constant; in addition, Medtronic's newer Activa system allows setting up groups of such settings to be used by the patient at home

- the BS Vercise, from the limited documentation released, allows more contacts longitudinally to be programmed independently ... but still no circumferential variation

- the Aleva Neutronics (Swiss university project) literature talks for the first time about a device with an array of sources allowing directional (circumferential) variation. I assume that the human patient testing in the reference article is being performed only in Europe

 

In another dimension, newer studies recognize that the Parkinson brain has a fluctuating resistance to the electric current, hence Adaptive field sensing and shaping may have benefits.

 

My concern in seeing such logical enhancements of the technology has already been voiced in previous posts on this forum: 

a. does the neurologist know enough about the location of various functional locations in the Subthalamic Nucleus for each PD symptom to be able to tailor the field successfully?

b. what percentage of DBS teams in the US today have the training and  are willing to take the time to go beyond just monopolar settings?

c. alternately, what teaming of a knowledgeable patient and programmer would allow for a "trial and error" adaptive convergence process in the long run? and for "as needed" adjustments to the fluctuations?

d. what insurance policy would allow the increased number of visits required to apply the technology.... over repeated far away hospital sessions, or possibly via telemedicine implementations?  Until the question a) above can be answered, I don't see how the marketing literature can boast of computer controlled adjustments.

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This is just a great post and I am going to approve it so others can read it.  There are no answers to any of these questions, however the field will need to work through them to ensure in the future a workable and meaningful solution can be delivered in a reasonable way across many countries and cultures.  There are a lot of exciting things going on in Deep Brain Stimulation, but we should not forget the questions raised by this post!

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