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Post of the Week: New Study on Constant Current DBS


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#1 Dr. Okun

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Posted 14 January 2012 - 10:48 AM

Dear forum members this was published in Lancet Neurology online this week.

Lancet Neurol. 2012 Jan 10. [Epub ahead of print]
Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial.
Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Tröster AI, Vitek JL, Tagliati M; for the SJM DBS Study Group.
Source
Department of Neurology, Center for Movement Disorders and Neurorestoration, University of Florida College of Medicine, Gainesville, FL, USA.
Abstract
BACKGROUND:
The effects of constant-current deep brain stimulation (DBS) have not been studied in controlled trials in patients with Parkinson's disease. We aimed to assess the safety and efficacy of bilateral constant-current DBS of the subthalamic nucleus.
METHODS:
This prospective, randomised, multicentre controlled trial was done between Sept 26, 2005, and Aug 13, 2010, at 15 clinical sites specialising in movement disorders in the USA. Patients were eligible if they were aged 18-80 years, had Parkinson's disease for 5 years or more, and had either 6 h or more daily off time reported in a patient diary of moderate to severe dyskinesia during waking hours. The patients received bilateral implantation in the subthalamic nucleus of a constant-current DBS device. After implantation, computer-generated randomisation was done with a block size of four, and patients were randomly assigned to the stimulation or control group (stimulation:control ratio 3:1). The control group received implantation without activation for 3 months. No blinding occurred during this study, and both patients and investigators were aware of the treatment group. The primary outcome variable was the change in on time without bothersome dyskinesia (ie, good quality on time) at 3 months as recorded in patients' diaries. Patients were followed up for 1 year. This trial is registered with ClinicalTrials.gov, number NCT00552474.
FINDINGS:
Of 168 patients assessed for eligibility, 136 had implantation of the constant-current device and were randomly assigned to receive immediate (101 patients) or delayed (35 patients) stimulation. Both study groups reported a mean increase of good quality on time after 3 months, and the increase was greater in the stimulation group (4·27 h vs 1·77 h, difference 2·51 [95% CI 0·87-4·16]; p=0·003). Unified Parkinson's disease rating scale motor scores in the off-medication, on-stimulation condition improved by 39% from baseline (24·8 vs 40·8). Some serious adverse events occurred after DBS implantation, including infections in five (4%) of 136 patients and intracranial haemorrhage in four (3%) patients. Stimulation of the subthalamic nucleus was associated with dysarthria, fatigue, paraesthesias, and oedema, whereas gait problems, disequilibrium, dyskinesia, and falls were reported in both groups.
INTERPRETATION:
Constant-current DBS of the subthalamic nucleus produced significant improvements in good quality on time when compared with a control group without stimulation. Future trials should compare the effects of constant-current DBS with those of voltage-controlled stimulation.
FUNDING:
St Jude Medical Neuromodulation Division.
Copyright © 2012 Elsevier Ltd. All rights reserved.

Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#2 mickirose

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Posted 01 July 2015 - 09:21 AM

Dr. Okun, could you please explain how the new generator which was recently approved by the FDA is different from any previous generator. Thank you in advance. Micki


64 yrs.old   Presented with R hand tremor 2002 Dx'd 2004  Multiiple meds gone through and tossed due to adverse side effects . Presently on Sinemet 1 1/4 25/100 7x/24 hrs., Paxil, lotrel, Lipitor,Prilosec. Have moderate bilateral tremors, rigidity, bradykinesia, moderate dyskinesia during "ON" time, poor fine motor and poor manual strength esp. on left. Slight softening of speech and pronunciation. Handwriting and computer use issues. DBS in near future.  Nana of 4 little beauties under 8 and 1 soon to arrive! Tai cHI for health and balance


#3 Dr. Okun

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Posted 02 July 2015 - 09:25 AM

The big difference is that it provides constant current instead of constant voltage.  The older generators use voltage and this can cause changes in the shape of the electrical field in the brain based on changes in brain tissue impedance.  So far studies have not shown constant current superior, but most devices will likely be made to support constant current in the future.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#4 mickirose

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Posted 02 July 2015 - 09:55 AM

Thanks for your quick response.  I am still somewhat confused regarding how it is  recharged.   I am afraid I don't understand the basic concept required to ask the right questions.  Is it rechargeable through the skin like a new generation IPhone? I am trying to decide which route to take as just had surgery done last week and presently awaiting implantation of generator.  Micki


64 yrs.old   Presented with R hand tremor 2002 Dx'd 2004  Multiiple meds gone through and tossed due to adverse side effects . Presently on Sinemet 1 1/4 25/100 7x/24 hrs., Paxil, lotrel, Lipitor,Prilosec. Have moderate bilateral tremors, rigidity, bradykinesia, moderate dyskinesia during "ON" time, poor fine motor and poor manual strength esp. on left. Slight softening of speech and pronunciation. Handwriting and computer use issues. DBS in near future.  Nana of 4 little beauties under 8 and 1 soon to arrive! Tai cHI for health and balance


#5 Dr. Okun

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Posted 02 July 2015 - 02:19 PM

You are locked to get the generator that matches your lead.  Recharge-able or not is a different issue than constant current.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#6 waruna01

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Posted 17 July 2015 - 05:36 PM

Would existing generators support constant current in the future?

#7 Dr. Okun

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Posted 18 July 2015 - 10:41 AM

Yes, the Medtronic PC and SC for example can be used in this mode.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#8 Neftali

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Posted 29 February 2016 - 11:45 PM

Dr Okun. Which is correct on bilateral DBS?
A) ALTERNATE FUNCTION ON ELECTRODES
B) SIMULTANEUS FUNCTION ON ELECTRODES
My father 74 yr old had a Dbs procedure on dec-16'. EP . Slow walk and speech problems. Since that datei cant see much changes. ¿could be somethig be wrong with position of electrodes? We arein Monterrey Mexico. Sorry about my English

#9 Neftali

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Posted 29 February 2016 - 11:46 PM

Dr Okun. Which is correct on bilateral DBS?
A) ALTERNATE FUNCTION ON ELECTRODES
B) SIMULTANEUS FUNCTION ON ELECTRODES
My father 74 yr old had a Dbs procedure on dec-16'. EP . Slow walk and speech problems. Since that datei cant see much changes. ¿could be somethig be wrong with position of electrodes? We arein Monterrey Mexico. Sorry about my English

#10 Dr. Okun

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Posted 05 March 2016 - 09:26 AM

Be careful as many patients actually worsen after bilateral DBS in walking and talking.  Sometimes it is a result of the surgery, but sometimes it is the programming or position of the lead.  These need to be carefully investigated.  In general DBS is not great for walking and balance though in some cases by improving on time, mobility also improves.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#11 waruna01

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Posted 05 March 2016 - 10:38 AM

Would constant current improve swallowing and speech?

#12 Dr. Okun

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Posted 05 March 2016 - 03:52 PM

In general I would say it is unlikely.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#13 janvier

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Posted 10 March 2016 - 04:35 PM

Dear Doctor, I have bilateral STN implanted with LibraXP of St Jude. The battery has about 6 years of longevity according to St Jude. Now I see that after 2 years and 3 months it is exhausted. This is confirmed by the representatives of the company. With a normal usage of the battery for PD is this normal. The company gives all kinds of reasons for this. Is there a certain threshold of parameters like the current in miliampers, the frequency, the polarity, etc so that beyond that threshold this happens. Thanks.



#14 Dr. Okun

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Posted 23 March 2016 - 05:52 PM

The battery life will depend on the parameters set on each device and on the battery itself.  If you want to share the contacts programmed and also the detailed parameters I can comment more.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#15 janvier

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Posted 31 March 2016 - 02:35 AM

Here are the parameters:

Brain left side Electrodes used 1 and 2, bipolar stimulation, current 4.2 milli ampers.

Brain right side Electrodes used 2 and 3, bipolar stimulation, current 0.1 milli ampers.

Electrodes numbered as 0,1,2,3.



#16 Dr. Okun

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Posted 02 April 2016 - 09:02 AM

The right sided lead is set very low and I would wonder why and if it may be sub optimally placed.  The left sided lead does not have particularly high settings for a bipolar configuration although some would say mildly high.  The company of the device (whichever one is the manufacturer) can estimate device longevity for you.  I would expect many years based on the above settings.  I didn't see the question on this thread but think that was what you were asking.  If not, feel free to follow-up.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#17 janvier

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Posted 05 April 2016 - 06:22 AM

Indeed I have consulted the experts of the manufacturer which is St Jude and inquired about the longevity of the battery. They tried to contact the IPG via the patient device which indicated that the battery is exhausted. Then they tried with their own strong antenna which managed to communicate with the IPG. In this case they declared that the battery will be off very soon probably in  a few days or weeks. Now nearly 7 weeks have gone by and the battery is still functioning. I tend to think that there is a software error which is strongly denied by the company. For my part I am perplexed and do not now who to believe.

As to the low current on the right side of the brain before having the bilateral DBS, 10 years ago I had a unilateral VIM to stop the tremor on my left side. At that time there was absolutely no symptom on the right side of the body. In order to minimize the risk that additional electrode was left in place. Merely the existence of the electrode in VIM reduces the current to 0.1 and even the target electrode has been changed from 1-2 to 2-3.

As to my Neurosurgeon and neurologist they believe what the company says although in the publicity the company declares that LIbraXP has 40% longer life than all other batteries on the market.

Any advice is welcome.Thanks.



#18 Dr. Okun

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Posted 08 April 2016 - 10:07 AM

I am not sure what else to advise.  It must be very frustrating!


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#19 janvier

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Posted 09 April 2016 - 11:47 AM

Frustrating as it is, I have one remark. Although by various manufacturers such as Medtronic, St Jude the battery longevity is announced and claimed as 5 to 7 years, in certain countries this number is taken by default as 2 to 3  years especially from insurance point of view. It seems to be only low level battery consumption below a certain voltage level such as 3.6 mV reaches that target. However this is never openly declared by the suppliers nor confirmed openly by the Neurosurgeons. On the other hand even if this was done publicly I doubt very much whether it will have any serious impact on the number of DBS operations undertaken yearly in the world, because a well performed DBS affects the PD patient like a miracle.



#20 Dr. Okun

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Posted 10 April 2016 - 10:07 AM

This is a very insightful comment.  Thanks for posting.


Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips





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