scholarly journals Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS) – Ethical considerations in the use of Implants and Bio-Medical responsibility at manufacture

Author(s):  
Хан Аref

Here in this brief we take a quick look into the use of certain biomedical devices and their benefits. At the same time, it is suggested that there are questionable practices by manufacturers, which raise concerns about corporate mores in general and around Ethics. As a Society, especially in these modern days, we need to be more aware of all that is going on and ensure accountability. Should not the primary objective be about saving lives and improving the quality of life, rather than putting the profit margin first. In this article we consider field of neuromodulation which is one of the fastest growing and the implantable devices such as pacemakers and IPGs. Let’s start off with a bit of background.

2020 ◽  
Vol 29 (4) ◽  
pp. 557-573
Author(s):  
KATRINA A. MUÑOZ ◽  
JENNIFER BLUMENTHAL-BARBY ◽  
ERIC A. STORCH ◽  
LAURA TORGERSON ◽  
GABRIEL LÁZARO-MUÑOZ

AbstractDystonia is a movement disorder that can have a debilitating impact on motor functions and quality of life. There are 250,000 cases in the United States, most with childhood onset. Due to the limited effectiveness and side effects of available treatments, pediatric deep brain stimulation (pDBS) has emerged as an intervention for refractory dystonia. However, there is limited clinical and neuroethics research in this area of clinical practice. This paper examines whether it is ethically justified to offer pDBS to children with refractory dystonia. Given the favorable risk-benefit profile, it is concluded that offering pDBS is ethically justified for certain etiologies of dystonia, but it is less clear for others. In addition, various ethical and policy concerns are discussed, which need to be addressed to optimize the practice of offering pDBS for dystonia. Strategies are proposed to help address these concerns as pDBS continues to expand.


2009 ◽  
Author(s):  
Hunter Covert ◽  
Pennie S. Seibert ◽  
Caitlin C. Otto ◽  
Missy Coblentz ◽  
Nicole Whitener ◽  
...  

Neurology ◽  
2017 ◽  
Vol 89 (19) ◽  
pp. 1944-1950 ◽  
Author(s):  
Matthew A. Brodsky ◽  
Shannon Anderson ◽  
Charles Murchison ◽  
Mara Seier ◽  
Jennifer Wilhelm ◽  
...  

Objective:To compare motor and nonmotor outcomes at 6 months of asleep deep brain stimulation (DBS) for Parkinson disease (PD) using intraoperative imaging guidance to confirm electrode placement vs awake DBS using microelectrode recording to confirm electrode placement.Methods:DBS candidates with PD referred to Oregon Health & Science University underwent asleep DBS with imaging guidance. Six-month outcomes were compared to those of patients who previously underwent awake DBS by the same surgeon and center. Assessments included an “off”-levodopa Unified Parkinson’s Disease Rating Scale (UPDRS) II and III, the 39-item Parkinson's Disease Questionnaire, motor diaries, and speech fluency.Results:Thirty participants underwent asleep DBS and 39 underwent awake DBS. No difference was observed in improvement of UPDRS III (+14.8 ± 8.9 vs +17.6 ± 12.3 points, p = 0.19) or UPDRS II (+9.3 ± 2.7 vs +7.4 ± 5.8 points, p = 0.16). Improvement in “on” time without dyskinesia was superior in asleep DBS (+6.4 ± 3.0 h/d vs +1.7 ± 1.2 h/d, p = 0.002). Quality of life scores improved in both groups (+18.8 ± 9.4 in awake, +8.9 ± 11.5 in asleep). Improvement in summary index (p = 0.004) and subscores for cognition (p = 0.011) and communication (p < 0.001) were superior in asleep DBS. Speech outcomes were superior in asleep DBS, both in category (+2.77 ± 4.3 points vs −6.31 ± 9.7 points (p = 0.0012) and phonemic fluency (+1.0 ± 8.2 points vs −5.5 ± 9.6 points, p = 0.038).Conclusions:Asleep DBS for PD improved motor outcomes over 6 months on par with or better than awake DBS, was superior with regard to speech fluency and quality of life, and should be an option considered for all patients who are candidates for this treatment.Clinicaltrials.gov identifier:NCT01703598.Classification of evidence:This study provides Class III evidence that for patients with PD undergoing DBS, asleep intraoperative CT imaging–guided implantation is not significantly different from awake microelectrode recording–guided implantation in improving motor outcomes at 6 months.


2018 ◽  
Vol 33 (7) ◽  
pp. 1160-1167 ◽  
Author(s):  
Elliot Hogg ◽  
Emmanuel During ◽  
Echo E. Tan ◽  
Kishore Athreya ◽  
Jonathan Eskenazi ◽  
...  

Neurology ◽  
2019 ◽  
Vol 92 (10) ◽  
pp. e1109-e1120 ◽  
Author(s):  
W.M. Michael Schuepbach ◽  
Lisa Tonder ◽  
Alfons Schnitzler ◽  
Paul Krack ◽  
Joern Rau ◽  
...  

ObjectiveTo investigate predictors for improvement of disease-specific quality of life (QOL) after deep brain stimulation (DBS) of the subthalamic nucleus (STN) for Parkinson disease (PD) with early motor complications.MethodsWe performed a secondary analysis of data from the previously published EARLYSTIM study, a prospective randomized trial comparing STN-DBS (n = 124) to best medical treatment (n = 127) after 2 years follow-up with disease-specific QOL (39-item Parkinson's Disease Questionnaire summary index [PDQ-39-SI]) as the primary endpoint. Linear regression analyses of the baseline characteristics age, disease duration, duration of motor complications, and disease severity measured at baseline with the Unified Parkinson’s Disease Rating Scale (UPDRS) (UPDRS-III “off” and “on” medications, UPDRS-IV) were conducted to determine predictors of change in PDQ-39-SI.ResultsPDQ-39-SI at baseline was correlated to the change in PDQ-39-SI after 24 months in both treatment groups (p < 0.05). The higher the baseline score (worse QOL) the larger the improvement in QOL after 24 months. No correlation was found for any of the other baseline characteristics analyzed in either treatment group.ConclusionImpaired QOL as subjectively evaluated by the patient is the most important predictor of benefit in patients with PD and early motor complications, fulfilling objective gold standard inclusion criteria for STN-DBS. Our results prompt systematically including evaluation of disease-specific QOL when selecting patients with PD for STN-DBS.Clinicaltrials.gov identifierNCT00354133.


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