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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 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 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 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 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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