PSG WORKING GROUPS

The six PSG Working Groups enable collaborations among investigators with related interests in PD. Their primary goal is to generate proposals for new research studies, either interventional or observational, as well as retrospective data mining projects. They provide a forum for initial discussion and feedback on research projects and clinical trials and are responsible for generating or facilitating proposals to submission to the Scientific Review Committee for further feedback and consideration before submitting proposals for funding. They meet via teleconference when needed and meet in person at least once a year (at the PSG Annual Meeting).

If you want to become a member or have an idea for a project, please contact the working group’s lead facilitator.  Contact information email link is listed under each working group description.

Want to get involved or have an idea for a project related to biomarkers in PD? Please contact us via email. 

Purpose:The primary goal of the Classic Motor Working Group is to generate proposals for new research studies, either interventional or observational, as well as retrospective data mining projects.

Current Projects:

• Tanya Simuni. STEADY-PD (Safety, Tolerability, and Efficacy Assessment of Dynacirc CR for PD) trial. The purpose of the study is to assess the general safety and tolerability of isradipine CR, to determine effective dosage of isradipine CR and obtain pilot data on the potential effect of isradipine on slowing the progression of PD. The trial is currently enrolling and please visit clinicaltrials .gov for a listing of participating sites.

• Roger Kurlan. “Aerobic Exercise as a Disease Modifying Intervention in Parkinson’s Disease”. After SRC review, it was recommended for approval as a PSG study. It has been submitted to the NIH, February 2010.

• Robert Hauser and Peggy Auinger. "Determination of Minimally Clinically Important Change in Early and Advanced PD". This datamining project was funded by PSG/PDF and analyses have been completed on the TEMPO and PRESTO studies. Results were presented at the PSG Annual Meeting in May 2009. Plans are underway to perform similar analyses with other available early PD and fluctuator studies to confirm results. If anyone has access to such databases they should email Peggy Auinger at peggy.auinger@ctcc.rochester.edu.

• Tanya Simuni. “Efficacy of Amantadine for Gait Freezing in Advanced Parkinson’s Disease”. The working group expressed interest in performing a controlled trial but a funding source would need to be identified. Dr. Simuni will circulate a revised synopsis to the working group members and it is planned to be discussed at the PSG Annual Meeting in May 2010.

• Susan Fox. " IV levodopa infusions to standardize assessment of wearing-off and dyskinesias in future dose-ranging and dose-finding clinical trials". With internal funding, Dr. Fox has moved forward with this trial.

Recent Publications/Projects:

1) The Working Group (PI: Ergun Uc) completed a data-mining study examining the clinical predictors and incidence of cognitive impairment and depression in early PD using the DATATOP cohort.

• The incidence of cognitive impairment in clinical trial participants in early PD was relatively low. The study found potential novel predictors of cognitive impairment in PD such as bulbar dysfunction and presence gastrointestinal/urologic symptoms suggestive of early autonomic dysfunction. These results were presented at the Derek Denny-Brown Symposium (2008 ANA meeting) by Dr. Uc and recently published in Neurology (Uc EY, McDermott MP, Marder KS, Anderson SW, Litvan I, Como P, Auinger P, Chou KL, Growdon J, on behalf of the Parkinson Study Group. Incidence of and Risk Factors for Cognitive Impairment in an Early Parkinson’s Disease Clinical Trial Cohort. Neurology, 2009; 73:1469–1477.).

• The results of the depression component were presented in a platform session at the 2009 AAN meeting (Uc EY, McDermott MP, Weintraub D, Marsh L, Growdon J, Chou K, Auinger P, Marder K, on behalf of the PSG DATATOP Investigators. Predictors of Depression in Early Parkinson's Disease. Neurology 2009; 72(11):A257-A258.) and a paper is being drafted.

2) Dr. Chou coordinated a task force to make recommendations for a cognitive assessment that could be consistently administered in clinical trials of PD. The Task Force conducted a systematic literature search for cognitive assessments previously used in a PD population. Scales were evaluated for their applicability in clinical trials, including administration time, assessment of the major cognitive domains, potential to detect subtle cognitive impairment, psychometric properties, and sensitivity to progression and to treatment effects. A manuscript has now been drafted and submitted for peer-review.

3) The Cognitive/Psychiatric Working Group sponsored the “Second Clifford W. Shults Symposium: Cognitive & Psychiatric Aspects of Parkinson’s Disease” on May 28, 2009 during the 21st Annual Meeting of the Parkinson Study Group. The organizing committee consisted of Drs. Uc (chair), Growdon, Chou, Marder and Ms. Marsha Tennis.

4) Dr. Karen Marder (Columbia University), along with Lorraine Clark, PhD, conducted a study on genotyping blood samples collected during the DATATOP study to determine the association between several PD related mutations with dementia incidence in PD. An abstract has been recently submitted to AAN 2010 for consideration.

Want to get involved or have an idea for a project related to cognitive or psychiatric (behavior) concerns in PD? Please contact us via email.

Current Projects:
• PPN Target for PD: The PPN project was reviewed favorably by the PSG Scientific Review Committee and we are addressing concerns and will resubmit. If the PSG approves the proposal we plan to try NIH, Medtronic, or ANS for funding. One small PPN project was recently not funded by NIH (with an excellent score), and we are therefore thinking of an industry partner. Chris Hass is currently handling the revision. The 5 DBS Centers involved in this project remain interested in pursuing the pilot trial, but statistical projections could change, requiring a few more sites. If your center is interested in the project and would like to be a back-up site, please contact okun@neurology.ufl.edu or cjhass@hhp.ufl.edu.

• Early STN DBS vs. medical management: Rajeev Kumar summarized his proposal to the group, where currently employed PD patients below 60 years of age were to be randomized to early STN DBS versus best medical therapy at the onset of their motor fluctuations. Several aspects of study design were debated including enrollment feasibility, outcome measurement, clinical equipoise, and study length. Rajeev Kumar will create a survey for patients (assessing their willingness to participate in such a study, if invited) and investigators (to determine 1: whether clinical equipoise is sufficient to permit this study to move forward and 2: what follow-up period would be required to answer the trial hypothesis).

• Zona Incerta Target for ET and PD: Hubert Fernandez summarized the data thus far on zona incerta DBS for ET and PD and asked the group about an STN versus ZI blinded preliminary trial. Some expressed their concern that there is not enough evidence on ZIs benefits to justify clinical equipoise in randomizing people to these targets. Discussion also centered around the surgical approach needed to capture both targets if DBS were to be compared within-subject. The consensus was to make a brief proposal for submission to the SRC, then to submit to the NIH (R34/Clinical Trial Grant) or MJFF. If you would like to be part of the 5-6 member steering committee of this project, please contact Hubert Fernandez or Robert Gross. If you would like to participate in the VIM versus ZI for ET project, please contact Serena Hung at the Medical College of Wisconsin (shung@mcw.edu).

• Grounded Theory Analysis of DBS Outcome: Hubert Fernandez and colleagues from the College of Nursing from the University of Florida submitted a “grounded theory project” on DBS to serve as pilot data for a multi-center qualitative project on DBS. Unfortunately, it was not funded by the NPF. We will find alternative sources of funding for this project. Any center interested in participating in this type of research, please contact Hubert Fernandez (fernandez@neurology.ufl.edu).

Want to get involved or have an idea for a project related to functional neurosurgical concerns in PD? Please contact us via email. 

• The NPF has funded our main project, “Impact of Commonly Prescribed Medications on PD Progression” (PI: Andrew Siderowf).  Construction of the meta-analytic database is underway.  Tanya Simuni is in charge of the analysis on calcium channel blockers.  Marie St. Hillaire and Ben Wolozin are working on statins.  An application was submitted by Timothy Collier to study anti-depressants and his project was funded by the Parkinson’s Disease Foundation.  This additional study will be coordinated with our project.
• Marian Evatt is investigating vitamin D levels in the DATATOP cohort.

Want to get involved or have an idea for a project related to genetic and environmental risk factors in PD? Please contact us via email. 

Purpose: The primary goal of the Other Non-Motor Working Group is to generate proposals for new research studies, either interventional or observational, as well as retrospective data mining projects. 

• Theresa Zesiewicz’s project, “URGE-PD: A Multi-Site, Double-Blind, Randomized, Placebo-Controlled Trial of Solifencain Succinate (VESIcare) for the Treatment of Urinary Dysfunction in Parkinson’s Disease,” presented for discussion.  Several trial design issues were debated including concomitant use of cholinesterase inhibitors, whether and how to assess subjective cognitive dysfunction, choice of primary outcome measure (reduction in number of micturitions per day rather than episodes of incontinence), as well as addressing budgetary questions and other administrative questions. The proposal was submitted for funding in January 2009.
• Ergun Uc. “Weight Loss in PD".  The analyses are almost completed. An abstract entitled "Weight Loss in PD across Different Stages" has been accepted for a poster presentation at the MDS 14th International Congress of PD and Movement Disorders 2010. Dr. Uc is also working on a manuscript for publication and plans to present an update at the working group meeting in May 2010.
• Ivan Bodis-Wollner. Potential project evaluating olfaction prospectively in the early stages of PD as a predictor for the development of cognitive impairment. Original data by Dr.Richard Doty shows that olfactory impairment is prevalent in early PD patients, but the deviant score does not correlate with motor impairment. In early patients we seek to evaluate the potential of olfactory impairment to predict later development of other, non-motor features of PD. Work continues on this project and further discussion will be at the working group meeting in May 2010.

Want to get involved or have an idea for a project related to other non-motor concerns in PD? Please contact us via email.