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A multicenter epidemiological and clinical study on deep brain stimulation (DBS) for Parkinson's disease: The pilot study*
Abstracts / Parkinsonism and Related Disorders 22 (2016) e87ee141
effective concentration ng/ml 4.0/0.1, tmax (mins) 10-60/5-30, t2 30-60/ 90-150, prolactin-lowering (hours) 2/6-10, metabolism by glucuronidation/p450 2D6, APO spontaneously forms highly reactive quinones which are mutagenic and strong local irritants (1) / no toxic metabolites. Local tolerability poor (very frequent local reactions)/reasonable (less than 1% drop-outs). Toxicology: no carcinogenicity studies/dose-dependent decrease in mammary tumors, prolactinomas, and mortality in female rats, no increase in tumors in 2 years’ studies in rats and mice, no organ damage. APO is unstable in solutions, thus need for sodium metabisulfite (cave asthma attacks). Both APO and LIS are radical scavengers. For sc infusion APO needs large volumes and large pumps to be renewed every day, LIS 4mg dissolved in 2ml can be infused with patch-pumps over 3 days and thus is more patient-friendly. *always first APO; LIS behind slash Conclusions: LIS sc infusion should be made available to PD patients as a safe and possibly superior alternative to APO sc infusion. References: 1. Rehse K, Piesker G, Horowski R: Arch Pharm (Weinheim) 1978;11:360363. P 2.092. A MULTICENTER EPIDEMIOLOGICAL AND CLINICAL STUDY ON DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE: THE PILOT STUDY* Emma Scelzo 1, Ettore Beghi 2, Manuela Rosa 1, Elisa Bianchi 2, Claudio Pacchetti 3, Angelo Antonini 4, Luigi Romito 5, Leonardo Lopiano 6, Nicola Modugno 7, Filippo Tamma 8, Alberto Priori 9. 1 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; 2 Istituto Mario Negri, Milano, Italy; 3 IRCCS Istituto Mondino, Pavia, Italy; 4 IRCCS San Camillo, Venezia, Italy; 5 Fondazione IRCCS Istituto Besta, Milano, Italy; 6 Ospedale San Giovanni Battista, Torino, Italy; 7 IRCCS Neuromed, Pozzilli, Italy; 8 degli Studi di Ospedale Miulli, Acquaviva delle Fonti, Italy; 9 Universita Milano, Milano, Italy Objectives: To assess whether and how deep brain stimulation (DBS) and pharmacological treatment impact on the development of long-term Parkinson’s disease (PD) complications. Methods: This is a multicenter retrospective long-term observational study in PD patients receiving DBS (surgical cohort, SC) and controls receiving the best standard medical treatment (patients eligible for surgery but in whom surgery was not performed; medical cohort, MC). A pilot study was undertaken in 49 age- and sex-matched pairs having at least 1 year follow-up from DBS or from the time of indication for surgery in controls. We studied the following endpoints: dementia, incontinence, falls, hospitalizations and mortality. We calculated the incidence rate (IR) for each endpoint using the Poisson model. To compare SC and MC we used adjusted rate ratios (adjRR) with 95% confidence intervals. Data were adjusted for age, disease duration, comorbidities, previous falls, and hospital admissions. Results: PD patients in the SC group had a lower risk of experiencing falls (adjRR¼0.41; 95%CI: 0.17-0.97; p¼0.0434). The risk of hospital admissions during follow-up was higher in the SC group than in the MC group (AdjRR 1.59; 95% CI 1.06-2.38)(p¼0.0242). Excluding hospitalizations related to DBS management, the SC group had a lower (non-significant) number of hospital admissions compared to the MC group (AdjRR¼0.80; 95%CI: 0.511.24)(p¼0.3151). The risk of dementia, incontinence and death were similar in the two groups. Conclusions: DBS in PD is more effective than standard medical treatment in preventing falls. The DBS impact on dementia, incontinence, hospitalizations and death requires confirmation in a larger sample. * The study was supported by Ricerca Finalizzata 2010 (RF-2010-2319551). P 2.093. A COMPARISON OF DEEP BRAIN STIMULATION AND CONTINUOUS INTRAJEJUNAL LEVODOPA INFUSION IN ADVANCED PARKINSON’S DISEASE: THE INVEST STUDY Daniel van Poppelen, Rob M.A. de Bie, Joke M. Dijk. Department of Neurology, Academic Medical Center, Amsterdam, Netherlands
e105
Introduction: The therapies deep brain stimulation (DBS) and continuous intrajejunal levodopa infusion (CLI) both are efficacious treatments of motor symptoms in advanced Parkinson’s disease (PD). They reduce medication induced motor fluctuations and dyskinesias. Moreover, they significantly improve quality of life. The costs of CLI seem higher. Yet, comparative knowledge with respect to effectiveness, complications and costs is lacking as a randomized controlled trial (RCT) comparing DBS and CLI has never been performed. As a result, there is unwanted variation in medical practice regarding treatment of advanced PD. Objectives: To compare costs and effectiveness of the therapies DBS and CLI in advanced PD. Methods: A prospective open label multicentre RCT is currently performed. A total of 66 PD patients with medication induced motor fluctuations will be randomised between DBS and CLI treatment. Patients not willing to be randomised are eligible for an observational patient-preference study. There are 6 assessment visits in the first year of treatment. The primary health economic outcomes are costs per unit on the quality of life scale PDQ-39 and costs per QALY (Quality Adjusted Life Years) at 12 months. Major secondary outcomes are quality of life, functional health and complications. Results: The study started in December 2014, results are expected in 2019. Conclusions: The INVEST study is the first randomised study to provide comparative knowledge on the therapies DBS and CLI in advanced PD. P 2.094. MULTICENTER EXPERIENCE OF MIXED DEEP BRAIN STIMULATION IMPLANTS FOR MOVEMENT DISORDERS Francesca Preda 1, Clarissa Cavandoli 2, Angelo Antonini 3, Roberto Massimo Mondani 5, Silvio Sarubbo 6, Andrea Eleopra 4, Manuela Pilleri 8, Michele Cavallo 9, Andrea Martinuzzi 7, Landi 10, Mariachiara Sensi 11. 1 Department of Neurology, Bussolengo, Italy; 2 Department of Neurology, Az. Ospedaliera San Gerardo, Monza, Italy; 3 Department of Neurology, IRCCS Ospedale San Camillo, Venezia, Italy; 4 Department of Neurology, Az. Ospedaliero-Universitaria Santa Maria della Misericordia, Udine, Italy; 5 Department of Neurosurgery, Az. OspedalieroUniversitaria Santa Maria della Misericordia, Udine, Italy; 6 Department of Neurosurgery, Azienda Provinciale per i Servizi Sanitari, Trento, Italy; 7 Department of Neurology, IRCCS Eugenio Medea- Polo Scientifico di Conegliano/Pieve di Soligo, Treviso, Italy; 8 Department of Neurology, Casa di Cura Villa Margherita-Arcugnano, VICENZA, Italy; 9 Department of Neurosurgery, Arcispedale S.Anna, Ferrara, Italy; 10 Department of Neurosurgery, Az. Ospedaliera San Gerardo, Monza, Italy; 11 Department of Neurology, Arcispedale S Anna, Ferrara, Italy Objectives: Current-controlled (CC) DBS devices have been recently approved for replacement of depleted voltage-controlled (CV) IPGs. New IPGs can be connected to previously implanted electrodes and extensions by the same or by different manufacturer through the use of an adaptor. In our series, leads, extensions and CC IPGs were by different manufactures, so such hybrid systems are referred as “mixed implant”. The aim of this retrospective data collection is to evaluate the safety and efficacy of CC stimulation in patients with previous CV long-lasting stimulation. Methods: Twenty-one patients with Parkinson’s disease or Dystonic syndrome underwent DBS IPG’s replacements from CV to CC devices. Clinical features, therapy satisfaction and programming settings were assessed before, 1 week, 3 and 6 months after replacements. Results: Clinical outcome of CC IPGs and was similar to those obtained with CV devices and remained stable at 6 months follow-up. 92% of patients and physicians were satisfied with mixed implants. Mixed replacement did not required more reprogramming sessions than those reported for CV substitutions, to reach the same clinical results. One electrode dysfunction (high impendence) and one IPG infection which lead to the explantation of DBS system occurred. Impedance values recorded in CV and CC IPGs were similar. Conclusions: The replacement of CV with CC IPGs is a safe and effective procedure. The rate of adverse events occurred after CC IPG replacement was comparable with that reported after CV IPG substitutions. References: 1. Lettieri C, Rinaldo S, Devigili G, et al. Clinical outcomes of deep brain
effective concentration ng/ml 4.0/0.1, tmax (mins) 10-60/5-30, t2 30-60/ 90-150, prolactin-lowering (hours) 2/6-10, metabolism by glucuronidation/p450 2D6, APO spontaneously forms highly reactive quinones which are mutagenic and strong local irritants (1) / no toxic metabolites. Local tolerability poor (very frequent local reactions)/reasonable (less than 1% drop-outs). Toxicology: no carcinogenicity studies/dose-dependent decrease in mammary tumors, prolactinomas, and mortality in female rats, no increase in tumors in 2 years’ studies in rats and mice, no organ damage. APO is unstable in solutions, thus need for sodium metabisulfite (cave asthma attacks). Both APO and LIS are radical scavengers. For sc infusion APO needs large volumes and large pumps to be renewed every day, LIS 4mg dissolved in 2ml can be infused with patch-pumps over 3 days and thus is more patient-friendly. *always first APO; LIS behind slash Conclusions: LIS sc infusion should be made available to PD patients as a safe and possibly superior alternative to APO sc infusion. References: 1. Rehse K, Piesker G, Horowski R: Arch Pharm (Weinheim) 1978;11:360363. P 2.092. A MULTICENTER EPIDEMIOLOGICAL AND CLINICAL STUDY ON DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE: THE PILOT STUDY* Emma Scelzo 1, Ettore Beghi 2, Manuela Rosa 1, Elisa Bianchi 2, Claudio Pacchetti 3, Angelo Antonini 4, Luigi Romito 5, Leonardo Lopiano 6, Nicola Modugno 7, Filippo Tamma 8, Alberto Priori 9. 1 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; 2 Istituto Mario Negri, Milano, Italy; 3 IRCCS Istituto Mondino, Pavia, Italy; 4 IRCCS San Camillo, Venezia, Italy; 5 Fondazione IRCCS Istituto Besta, Milano, Italy; 6 Ospedale San Giovanni Battista, Torino, Italy; 7 IRCCS Neuromed, Pozzilli, Italy; 8 degli Studi di Ospedale Miulli, Acquaviva delle Fonti, Italy; 9 Universita Milano, Milano, Italy Objectives: To assess whether and how deep brain stimulation (DBS) and pharmacological treatment impact on the development of long-term Parkinson’s disease (PD) complications. Methods: This is a multicenter retrospective long-term observational study in PD patients receiving DBS (surgical cohort, SC) and controls receiving the best standard medical treatment (patients eligible for surgery but in whom surgery was not performed; medical cohort, MC). A pilot study was undertaken in 49 age- and sex-matched pairs having at least 1 year follow-up from DBS or from the time of indication for surgery in controls. We studied the following endpoints: dementia, incontinence, falls, hospitalizations and mortality. We calculated the incidence rate (IR) for each endpoint using the Poisson model. To compare SC and MC we used adjusted rate ratios (adjRR) with 95% confidence intervals. Data were adjusted for age, disease duration, comorbidities, previous falls, and hospital admissions. Results: PD patients in the SC group had a lower risk of experiencing falls (adjRR¼0.41; 95%CI: 0.17-0.97; p¼0.0434). The risk of hospital admissions during follow-up was higher in the SC group than in the MC group (AdjRR 1.59; 95% CI 1.06-2.38)(p¼0.0242). Excluding hospitalizations related to DBS management, the SC group had a lower (non-significant) number of hospital admissions compared to the MC group (AdjRR¼0.80; 95%CI: 0.511.24)(p¼0.3151). The risk of dementia, incontinence and death were similar in the two groups. Conclusions: DBS in PD is more effective than standard medical treatment in preventing falls. The DBS impact on dementia, incontinence, hospitalizations and death requires confirmation in a larger sample. * The study was supported by Ricerca Finalizzata 2010 (RF-2010-2319551). P 2.093. A COMPARISON OF DEEP BRAIN STIMULATION AND CONTINUOUS INTRAJEJUNAL LEVODOPA INFUSION IN ADVANCED PARKINSON’S DISEASE: THE INVEST STUDY Daniel van Poppelen, Rob M.A. de Bie, Joke M. Dijk. Department of Neurology, Academic Medical Center, Amsterdam, Netherlands
e105
Introduction: The therapies deep brain stimulation (DBS) and continuous intrajejunal levodopa infusion (CLI) both are efficacious treatments of motor symptoms in advanced Parkinson’s disease (PD). They reduce medication induced motor fluctuations and dyskinesias. Moreover, they significantly improve quality of life. The costs of CLI seem higher. Yet, comparative knowledge with respect to effectiveness, complications and costs is lacking as a randomized controlled trial (RCT) comparing DBS and CLI has never been performed. As a result, there is unwanted variation in medical practice regarding treatment of advanced PD. Objectives: To compare costs and effectiveness of the therapies DBS and CLI in advanced PD. Methods: A prospective open label multicentre RCT is currently performed. A total of 66 PD patients with medication induced motor fluctuations will be randomised between DBS and CLI treatment. Patients not willing to be randomised are eligible for an observational patient-preference study. There are 6 assessment visits in the first year of treatment. The primary health economic outcomes are costs per unit on the quality of life scale PDQ-39 and costs per QALY (Quality Adjusted Life Years) at 12 months. Major secondary outcomes are quality of life, functional health and complications. Results: The study started in December 2014, results are expected in 2019. Conclusions: The INVEST study is the first randomised study to provide comparative knowledge on the therapies DBS and CLI in advanced PD. P 2.094. MULTICENTER EXPERIENCE OF MIXED DEEP BRAIN STIMULATION IMPLANTS FOR MOVEMENT DISORDERS Francesca Preda 1, Clarissa Cavandoli 2, Angelo Antonini 3, Roberto Massimo Mondani 5, Silvio Sarubbo 6, Andrea Eleopra 4, Manuela Pilleri 8, Michele Cavallo 9, Andrea Martinuzzi 7, Landi 10, Mariachiara Sensi 11. 1 Department of Neurology, Bussolengo, Italy; 2 Department of Neurology, Az. Ospedaliera San Gerardo, Monza, Italy; 3 Department of Neurology, IRCCS Ospedale San Camillo, Venezia, Italy; 4 Department of Neurology, Az. Ospedaliero-Universitaria Santa Maria della Misericordia, Udine, Italy; 5 Department of Neurosurgery, Az. OspedalieroUniversitaria Santa Maria della Misericordia, Udine, Italy; 6 Department of Neurosurgery, Azienda Provinciale per i Servizi Sanitari, Trento, Italy; 7 Department of Neurology, IRCCS Eugenio Medea- Polo Scientifico di Conegliano/Pieve di Soligo, Treviso, Italy; 8 Department of Neurology, Casa di Cura Villa Margherita-Arcugnano, VICENZA, Italy; 9 Department of Neurosurgery, Arcispedale S.Anna, Ferrara, Italy; 10 Department of Neurosurgery, Az. Ospedaliera San Gerardo, Monza, Italy; 11 Department of Neurology, Arcispedale S Anna, Ferrara, Italy Objectives: Current-controlled (CC) DBS devices have been recently approved for replacement of depleted voltage-controlled (CV) IPGs. New IPGs can be connected to previously implanted electrodes and extensions by the same or by different manufacturer through the use of an adaptor. In our series, leads, extensions and CC IPGs were by different manufactures, so such hybrid systems are referred as “mixed implant”. The aim of this retrospective data collection is to evaluate the safety and efficacy of CC stimulation in patients with previous CV long-lasting stimulation. Methods: Twenty-one patients with Parkinson’s disease or Dystonic syndrome underwent DBS IPG’s replacements from CV to CC devices. Clinical features, therapy satisfaction and programming settings were assessed before, 1 week, 3 and 6 months after replacements. Results: Clinical outcome of CC IPGs and was similar to those obtained with CV devices and remained stable at 6 months follow-up. 92% of patients and physicians were satisfied with mixed implants. Mixed replacement did not required more reprogramming sessions than those reported for CV substitutions, to reach the same clinical results. One electrode dysfunction (high impendence) and one IPG infection which lead to the explantation of DBS system occurred. Impedance values recorded in CV and CC IPGs were similar. Conclusions: The replacement of CV with CC IPGs is a safe and effective procedure. The rate of adverse events occurred after CC IPG replacement was comparable with that reported after CV IPG substitutions. References: 1. Lettieri C, Rinaldo S, Devigili G, et al. Clinical outcomes of deep brain