Placebo effect of medication cost in Parkinson disease
A randomized double-blind study
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Article Information
- Received March 18, 2014
- Accepted in final form October 2, 2014
- First Published January 28, 2015.
Article Versions
- Previous version (January 28, 2015 - 13:01).
- You are viewing the most recent version of this article.
Author Disclosures
- Alberto J. Espay, MD, MSc,
- Matthew M. Norris, MEng,
- James C. Eliassen, PhD,
- Alok Dwivedi, PhD,
- Matthew S. Smith, BS,
- Christi Banks, CCRC,
- Jane B. Allendorfer, PhD,
- Anthony E. Lang, MD, FRCPC,
- David E. Fleck, PhD,
- Michael J. Linke, PhD and
- Jerzy P. Szaflarski, MD, PhD
- Alberto J. Espay, MD, MSc,
Solvay (now Abbvie), Chelsea Therapeutics, TEVA, Impax, Merz, Pfizer, Solstice Neurosciences, Eli Lilly, and USWorldMeds
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Associate Editor of Movement Disorders, Frontiers in Movement Disorders and Journal of Clinical Movement Disorders and on the editorial boards of Parkinsonism and Related Disorders and The European Neurological Journal.
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from Lippincott, Williams & Wilkins and from Cambridge University Press
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Consultant for Chelsea Therapeutics, Abbvie
UCB, TEVA, American Academy of Neurology, Movement Disorders Society
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NIH (1K23MH092735)
CleveMed/Great Lakes Neurotechnologies
Michael J Fox Foundation
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- Matthew M. Norris, MEng,
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- James C. Eliassen, PhD,
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(1) University of Wisconsin, Milwaukee, consultant on NIDA grant to Krista Medina.
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(1) Procter & Gamble, supported fMRI study of a consumer product.
K23 MH092735 (10%) Espay 2011-2016 NIH/NIMH PSYCHOGENIC TREMOR: FUNCTIONAL MAGNETIC RESONANCE STUDY ON EMOTIONAL PROCESSING. This study seeks to understand what changes occur in the activity of the brain of people with psychogenic tremor and how cognitive behavioral therapy may help to treat the tremor and psychological profile of patients. Role: Consultant. Mayfield Education Research Fund (5%) Kosty 2013-2015 Use of Diffusion Tensor Imaging to evaluate the effects of minimally invasive surgical evacuation of intracerebral hemorrhage on the corticospinal tract This study examines the potential for DTI to predict surgical outcomes in patients with traumatic brain injury. Role: Co-Investigator. Procter and Gamble (0%) Eliassen 2013-2014 This small study is covered by a confidentiality disclosure agreement. We will examine the effects of a consumer product on brain activity. Role: sub-contract PI. Just-In-Time Core Grant (0%) Eliassen 2012-2013 University of Cincinnati Academic Health Center, Center for Clinical and Trainslational Science and Training Predicting discontinuation of methadone maintenance therapy with functional MRI. This grant supports the recruitment and brain scanning of patients currently receiving methadone maintenance therapy and will assess whether functional brain activation can predict treatment retention. R01 AG034617 (10%) Krikorian (PI) 2009-2012 NIH/NIA,OD OMEGA-3 AND BLUEBERRY SUPPLMENTATION IN AGE-RELATED COGNITIVE DECLINE. As an initial step to establish early intervention and prevention strategies, this application proposes a double-bind placebo-controlled treatment trial to evaluate the neurocognitive benefits of combined omega-3 fatty acid and blueberries in elderly subjects at risk for age-related cognitive decline. Role: Co-investigator UC Neuroscience Institute (0%) Divine and Adler (PI?s) 2013-2014 Evidence of Neuropathic Changes in College Football Players. This study uses functional and structural brain imaging to identify the consequences of football head injuries. Role: Consultant. R15 DC011004 (0%) Zhang (PI) 2010-2013 NIH/NIDA TEMPORAL PROCESSING PROPERTIES OF THE AUDITORY SYSTEM IN COCHLEAR IMPLANT SYSTEMS. The goal of this project is to investigate the temporal properties of four types of auditory evoked potentials (AEPs) in CI patients: 1) the electric compound action potential (ECAP), 2) the electric auditory brainstem response (EABR), 3) the electric late auditory evoked potential (ELAEP), and 4) the acoustic LAEP. Role: Co-investigator. R01 DA030354 (0%) Medina (PI) 2011-2016 NIH/NIDA Effects of Physical Activity & Marijuana Use on Frontolimbic Functioning During Adolescence: An fMRI Study. This project will establish whether physical activity and cardiorespiratory fitness normalize the negative consequences of MJ exposure on frontal and limbic neocortical functioning during adolescence. Role: Consultant. K23 MH081214 (0%) Cerullo (PI) 2008-2013 NIH/NIDA IDENTIFYING THE CORE BRAIN NETWORK DYSFUNCTION IN BIPOLAR DEPRESSION WITH FMRI. We propose to use fMRI to compare regional brain activation between bipolar and unipolar depressed patients using a task designed to evaluate both the emotional and cognitive networks and their intersection. Role: Consultant. 1 P50 MH077138 (5%) Strakowski (PI) 2007-2012 (No Cost Ext. 6/30/13) NIH/NIDA U. of Cincinnati Bipolar Disorder Imaging & Treatment Research Center (BITREC) This proposal seeks to establish a Mental Health Center for Intervention Development and Applied Research (CIDAR) from the University of Cincinnati College of Medicine, Cincinnati, Ohio. The proposed projects will conduct a series of studies that will integrate magnetic resonance imaging (MRI) and spectroscopy (MRS) measures with outcome measures in clinical trials designed to identify trait and state aspects of selected metabolism markers which can be used as specific markers of treatment response and illness progression. Role: Co-investigator. K25 MH085103 (0%) Chu (PI) 2010-2012 NIH/NIDA CONTRASTING GLUTAMATERGIC NEUROTRANSMISSION IN BIPOLAR DISORDER AND SCHIZOPHRENIA. The scientific goal of this proposal is to differentiate the neuropathology of bipolar disorder and schizophrenia using functional MRI (fMRI)-guided MRS. Role: Consultant. F30 MH081461 (0%) Lamy (PI) 2008-2013 NIH/NIDA NEURAL MECHANISMS OF IMPULSIVITY AND REWARD PROCESSING IN BIPOLAR DISORDER This project investigates the neural mechanism of impulsivity and reward processing in bipolar disorder using a delay discounting task where subjects decide between monetary gains at different times. Role: Co-sponsor 1 K01 DA020485-01A1 (90%) Eliassen (PI) 2006-2011 (No Cost Ext. 8/31/2012) NIH/NIDA Linking serotonin and memory functions in MDMA users by concurrent EEG and fMRI. This project examines the hypothesis that serotonergic neurotoxicity causes the learning and memory impairments in recreational MDMA users by examining the electrophysiological markers of memory processing and serotonergic function using concurrent EEG and fMRI. Role: Principal Investigator. R03 DA027457 (0%) Medina (PI) 2009-2011(No Cost Ext. 2012) NIH/NIDA EFFECTS OF SLC6A4, BDNF AND ECSTASY USE ON BRAIN STRUCTURE IN YOUNGADULTS. Our primary aim is to determine whether ecstasy use, in combination with genotypes associated with low serotonin signaling, predicts poorer cognitive function and frontolimbic structural abnormalities in young adult ecstasy users, after controlling for polydrug use. Role: Co-investigator.
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- Alok Dwivedi, PhD,
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- Matthew S. Smith, BS,
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- Christi Banks, CCRC,
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- Jane B. Allendorfer, PhD,
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(1) Restorative Neurology and Neuroscience, Associate Editor, 2012-present
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(1) National Institutes of Health, R01 NS048281, Co-Investigator, 2008-2014, (2) National Institutes of Health, R01 HD068488, Co-Investigator, 2012-2016, (3) National Institutes of Health, R01 NS035929, Co-Investigator, 2011-2016 (4) Department of Defense , PT 130232, Co-Investigator, 2014-2017
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(1) Charles Shor Foundation for Epilepsy Research
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- Anthony E. Lang, MD, FRCPC,
Abbvie, Allon Therapeutics, Avanir Pharmaceuticals, Biogen Idec, Boerhinger-Ingelheim, Ceregene, Lilly, Medtronic, Merck, Novartis, NeuroPhage Pharmaceuticals, Teva and UCB.
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Teva, AbbVie, UCB
Movement Disorders:Clinical Practice Journal of Neurology, Neurosurgery and Psychiatry
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Schapira A, Lang AE, Fahn S. Movement Disorders 4. Saunders, Elsevier, Philadelphia, PA 2009. Olanow CW, Stocchi F, Lang AE. The Non-motor and Non- Dopaminergic Features of Parkinson?s Disease. Wiley- Blackwell, UK. 2011. Weiner WJ, Shulman LM, Lang AE. Parkinson?s Disease: A Complete Guide for Patients and Families. The Johns Hopkins University Press, Baltimore. 2001 Receives publishing royalties from Cambridge University Press.
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Brain Canada, Canadian Institutes of Health Research Ontario Brain Institute
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Edmond J Safra Philanthropic Foundation, Michael J. Fox Foundation, National Parkinson Foundation, Parkinson Society Canada, Tourette Syndrome Association, W. Garfield Weston Foundation
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Has served as an expert witness in cases related to the welding industry.
- David E. Fleck, PhD,
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- Michael J. Linke, PhD and
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Active VA Merit Review (Cushion) 6/1/2010- 6/1/2015 Department of Veterans Affairs Immunopathology of the life cycle stages of Pneumocystis. The major goals of this project are to identify the role of Pneumocystis trophic and cyst forms in pathophysiology. Dr. Linke has had a long-standing collaboration with Dr. Cushion that spans basic discovery science as illustrated by this Merit Review and in preclinical drug discovery as illustrated below. During the tenure of this Merit, Dr. Linke directed and analyzed the data from the immunological studies that were designed to investigate the differential responses to trophs vs cysts exposed to echinocandin treatment vs non- exposed. A manuscript with these results is currently in preparation, Linke, MJ, Ashbaugh, A, Collins, MS Lynch, K, Cushion, MT Pneumocystis murina Asci Stimulate Continued Inflammatory Responses following Resolution of Pneumocystis. Role: Co investigator HHSN272201000029I/HHSN2720003 (Cushion) 7/24/14-7/23/15 NIH-NIAID-DMID IDIQ Antimicrobial Assessment Contract Animal Models of Infectious Diseases. The major goals of this project are to develop novel anti Pneumocystis compounds. Dr. Linke has been the director of the VA subaward to this contract which is responsible for all the therapeutic and prophylactic studies in the mouse model of PCP. He also directs the mouse experiments designed to assess the pharmacodynamics and pharmacokinetics of the test compounds. Such experience is essential for the success of the present proposal. A manuscript from the previous task order (below) has been submitted: Mor, V, Rella, A, Singh, A, Farnoud, A, Munshi, M, Bryan, A, Naseem, S, Konopka J, Ojima I, Bullesbach E, Ashbaugh A, Linke M, Cushion M, Ananthula H, Desai P, Wiederhold N, Fothergill A, Kirkpatrick W, Patterson T, Nislow C, Pan X, Movva, R, Cesar, G, Frases S, Miranda K, Rodrigues M, Luberto C, Nimrichter L and Del Poeta M Identification of a new class of antifungals targeting the synthesis of fungal sphingolipids. The Journal of Clinical Investigation (submitted July 2014) Role: Sub award PI Completed Research Support A12008041 (Cushion) 4/1/2013-4/1/2014 NIH-NIAID-DMID IDIQ Antimicrobial Assessment Contract Animal Models of Infectious Diseases. The major goals of this project are to develop novel anti Pneumocystis compounds. This is a previous task order within the same contracting mechanism as described above. Role: Subcontract PI VA Merit Review (Wagner) 4/1/2010-4/1/2014 Department of Veterans Affairs Combined therapy for intracerebral hemorrhage treatment The major goals of this project are to develop novel therapies for intracerebral hemorrhage. Dr. Linke has collaborated with other investigators at the VA, in this case Dr. Ken Wagner, for the purposes of drug development. His extensive experience in this area will serve the present proposal well. Role: Co investigator
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- Jerzy P. Szaflarski, MD, PhD
Biomedical Systems, Inc
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2014- Editorial Board Member, Folia Medica Copernicana (http://czasopisma.viamedica.pl/fmc/) 2013- Editorial Board Member, Journal of Medical Science (www.nowinylekarskie.ump.edu.pl/) 2013- Associate Editor, Restorative Neurology and Neuroscience(www.iospress.nl/journal/restorative-neurology-and-neuroscience/) 2010- Editorial Board Member, Journal of Epileptology (http://www.journal-epileptology.com) 2006- Editorial Board Member, Epilepsy and Behavior (www.elsevier.com/locate/yebeh)
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Biomedical Systems, Inc, Compumedics Neuroscan (equipment only), SAGE Therapeutics (site PI)
NIH R21 MH103828 (Consultant), NIH R01 MH102951 (Co-Investigator), DoD PT130232 (Co-Investigator), Human Epilepsy Project (site Co-PI), University of Alabama at Birmingham Department of PM&R (PI), NIH K23 EB008452 (mentor), NIH R01 NS080898 (Co-Investigator), NIH R01 HD068488 (PI), EQUIGEN studies - University of Cincinnati (site PI), NIH K23 MH092735 (mentor), NIH R01 NS065840 (subcontract PI), NIH R01 NS035929 (subcontract PI), NIH R01 NS048281 (PI)
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Charles Shor Foundation for Epilepsy Research (Co-PI)
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Medico-legal expert
- From the UC Neuroscience Institute, Department of Neurology (A.J.E., C.B., J.P.S.), and Department of Internal Medicine (M.J.L.), University of Cincinnati; Gardner Family Center for Parkinson's Disease and Movement Disorders (A.J.E.), Cincinnati; University of Cincinnati Center for Imaging Research (M.M.N., J.C.E., M.S.S., D.E.F.), OH; Division of Biostatistics and Epidemiology (A.D.), Texas Tech University Health Sciences Center, El Paso; The Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease (A.E.L.), University Health Network and the University of Toronto, Canada; University of Alabama at Birmingham (J.B.A., J.P.S.); and Department of Veterans Affairs Medical Center (M.J.L.), Research Service, Cincinnati, OH.
- Correspondence to Dr. Espay: alberto.espay{at}uc.edu
Article usage
Cited By...
Letters: Rapid online correspondence
- Calibrated use of deception in assessing the placebo effect
- Alberto J Espay, Principal Investigator, University of Cincinnatiaespay@gmail.com
- Alok Dwivedi, El Paso, TX; Anthony E. Lang, Toronto, CA; Michael J. Linke, Cincinnati, OH; Jerzy P. Szaflarski, Birmingham, AL
Submitted February 11, 2015 - Should we tap patients beliefs?
- Alain Braillon, Senior consultant, University hospital. 8000 Amiens. Francebraillon.alain@gmail.com
Submitted February 10, 2015 - An Alternative Explanation of the Results
- John M. Kelley, Deputy Director, Program in Placebo Studies, Harvard Medical Schooljkelley@endicott.edu
Submitted February 06, 2015
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