scholarly journals Reduced Programming Time and Strong Symptom Control Even in Chronic Course Through Imaging-Based DBS Programming

2021 ◽  
Vol 12 ◽  
Author(s):  
Florian Lange ◽  
Frank Steigerwald ◽  
Tobias Malzacher ◽  
Gregor Alexander Brandt ◽  
Thorsten Michael Odorfer ◽  
...  

Objectives: Deep brain stimulation (DBS) programming is based on clinical response testing. Our clinical pilot trial assessed the feasibility of image-guided programing using software depicting the lead location in a patient-specific anatomical model.Methods: Parkinson's disease patients with subthalamic nucleus-DBS were randomly assigned to standard clinical-based programming (CBP) or anatomical-based (imaging-guided) programming (ABP) in an 8-week crossover trial. Programming characteristics and clinical outcomes were evaluated.Results: In 10 patients, both programs led to similar motor symptom control (MDS-UPDRS III) after 4 weeks (medicationOFF/stimulationON; CPB: 18.27 ± 9.23; ABP: 18.37 ± 6.66). Stimulation settings were not significantly different, apart from higher frequency in the baseline program than CBP (p = 0.01) or ABP (p = 0.003). Time spent in a program was not significantly different (CBP: 86.1 ± 29.82%, ABP: 88.6 ± 29.0%). Programing time was significantly shorter (p = 0.039) with ABP (19.78 ± 5.86 min) than CBP (45.22 ± 18.32).Conclusion: Image-guided DBS programming in PD patients drastically reduces programming time without compromising symptom control and patient satisfaction in this small feasibility trial.

2015 ◽  
Vol 17 (suppl 5) ◽  
pp. v161.1-v161
Author(s):  
Andrea Hawkins-Daarud ◽  
Hani Malone ◽  
Timothy Ung ◽  
Anthony Rosenberg ◽  
Joshua Jacobs ◽  
...  

Author(s):  
Jonathan Shapey ◽  
Thomas Dowrick ◽  
Rémi Delaunay ◽  
Eleanor C. Mackle ◽  
Stephen Thompson ◽  
...  

Abstract Purpose Image-guided surgery (IGS) is an integral part of modern neuro-oncology surgery. Navigated ultrasound provides the surgeon with reconstructed views of ultrasound data, but no commercial system presently permits its integration with other essential non-imaging-based intraoperative monitoring modalities such as intraoperative neuromonitoring. Such a system would be particularly useful in skull base neurosurgery. Methods We established functional and technical requirements of an integrated multi-modality IGS system tailored for skull base surgery with the ability to incorporate: (1) preoperative MRI data and associated 3D volume reconstructions, (2) real-time intraoperative neurophysiological data and (3) live reconstructed 3D ultrasound. We created an open-source software platform to integrate with readily available commercial hardware. We tested the accuracy of the system’s ultrasound navigation and reconstruction using a polyvinyl alcohol phantom model and simulated the use of the complete navigation system in a clinical operating room using a patient-specific phantom model. Results Experimental validation of the system’s navigated ultrasound component demonstrated accuracy of $$<4.5\,\hbox {mm}$$ < 4.5 mm and a frame rate of 25 frames per second. Clinical simulation confirmed that system assembly was straightforward, could be achieved in a clinically acceptable time of $$<15\,\hbox {min}$$ < 15 min and performed with a clinically acceptable level of accuracy. Conclusion We present an integrated open-source research platform for multi-modality IGS. The present prototype system was tailored for neurosurgery and met all minimum design requirements focused on skull base surgery. Future work aims to optimise the system further by addressing the remaining target requirements.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e044200
Author(s):  
Fiona Jane Kinnear ◽  
Fiona E Lithander ◽  
Aidan Searle ◽  
Graham Bayly ◽  
Christina Wei ◽  
...  

ObjectiveFamilial hypercholesterolaemia (FH) elevates low-density lipoprotein cholesterol (LDL-C) and increases cardiovascular disease (CVD) risk. This study aimed to provide evidence for the feasibility of conducting a randomised controlled trial to evaluate the efficacy of an intervention designed to improve diet and physical activity in families with FH.DesignA parallel, randomised, waitlist-controlled, feasibility pilot trial.SettingThree outpatient lipid clinics in the UK.ParticipantsFamilies that comprised children (aged 10–18 years) and their parent with genetically diagnosed FH.InterventionFamilies were randomised to either 12-week usual care or intervention. The behavioural change intervention aimed to improve dietary, physical activity and sedentary behaviours. It was delivered to families by dietitians initially via a single face-to-face session and then by four telephone or email follow-up sessions.Outcome measuresFeasibility was assessed via measures related to recruitment, retention and intervention fidelity. Postintervention qualitative interviews were conducted to explore intervention acceptability. Behavioural (dietary intake, physical activity and sedentary time) and clinical (blood pressure, body composition and blood lipids) outcomes were collected at baseline and endpoint assessments to evaluate the intervention’s potential benefit.ResultsTwenty-one families (38% of those approached) were recruited which comprised 22 children and 17 adults with FH, and 97% of families completed the study. The intervention was implemented with high fidelity and the qualitative data revealed it was well accepted. Between-group differences at the endpoint assessment were indicative of the intervention’s potential for improving diet in children and adults. Evidence for potential benefits on physical activity and sedentary behaviours was less apparent. However, the intervention was associated with improvements in several CVD risk factors including LDL-C, with a within-group mean decrease of 8% (children) and 10% (adults).ConclusionsThe study’s recruitment, retention, acceptability and potential efficacy support the development of a definitive trial, subject to identified refinements.Trial registration numberISRCTN24880714.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e054115
Author(s):  
Philippe C Wouters ◽  
Chris van Lieshout ◽  
Vincent F van Dijk ◽  
Peter-Paul HM Delnoy ◽  
Pieter AFM Doevendans ◽  
...  

IntroductionAchieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here.Methods and analysisA multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states.Ethics and disseminationThe protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals.Trial registration numberNCT05053568; Trial NL8666.


2016 ◽  
Vol 25 (4) ◽  
pp. 201-206
Author(s):  
Augustine Joshua Devasahayam ◽  
Doreen Ren Yan Ho ◽  
Elsa Yee Sum Leung ◽  
Ming Rong Goh ◽  
Patricia Koh

Background: Pain alters the neuromuscular activation and results in altered movement adaptations. A new exercise prescription method proposes that we can restore the neuromuscular control by rehabilitating the deficient neural drive through Pilates exercises. This is done by identifying the postural control deficits using single-leg tests such as hopping, half squats and heel raises. The aim of this study was to find out if this method of prescribing exercises results in clinically relevant outcomes. Methods: Fifteen patients with chronic non-specific low back pain with unilateral musculoskeletal pain were recruited. Following consent, all patients were randomly assigned either to perform gym or Pilates-based individualised exercises once weekly for six weeks. The primary outcome was to measure the pain intensity using a 0–10 numerical rating scale. The secondary outcome measures were: the global perceived effect scale (GPE; 0–10), the patient-specific functional scale (PSFS; the patient-generated measure of disability) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; the condition-specific measure of disability). Results: There were statistically significant differences noted after intervention within the control group in the numerical rating scale ( P=0.041), GPE ( P=0.024), PSFS ( P=0.039) and within the experimental group in the WOMAC ( P=0.008), GPE ( P=0.007) and PSFS ( P=0.007). However, as there were clinically significant baseline differences, the within-group difference could be due to regression to the mean. There were no statistically significant results between the two groups after intervention. Conclusion: This new prescription method for Pilates-based exercises may improve disability and global perception of recovery. However, the outcomes are not different from a regular gym-based exercise programme.


2020 ◽  
Vol 39 (9) ◽  
pp. 2760-2771 ◽  
Author(s):  
Chengyue Wu ◽  
David A. Hormuth ◽  
Todd A. Oliver ◽  
Federico Pineda ◽  
Guillermo Lorenzo ◽  
...  

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