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A Study of Neurophysiologic Changes in Individuals with Parkinson''s Disease - Article


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Wolff-Parkinson-White Syndrome

WPW 




Clinical Trial: A Study of Neurophysiologic Changes in Individuals with Parkinson''s Disease

This study is currently recruiting patients.

Sponsors and Collaborators: Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Information provided by: Institute for Neurodegenerative Disorders

Purpose

The goal of this study is to investigate neurophysiologic tests that have the potential of serving as screening tools for Parkinson''''s disease. These neurophysiologic tests will be administered to individuals with Parkinson''''s disease and parkinsonian syndrome and validated against a healthy control population.

Specifically, this study will look at changes in motor function, cognitive function, handwriting, speech, and olfactory function in individuals with Parkinson''''s disease, individuals at risk for Parkinson''''s disease and healthy controls.

Condition Intervention
Parkinson''''s Disease
Parkinsonian Syndrome
 Device: Automated Neuropsychological Assessment Matrix

MedlinePlus related topics:  Brain Diseases;   Movement Disorders;   Parkinson''''s Disease
Genetics Home Reference related topics:  Parkinson disease

Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study

Official Title: Open-Label Validation Study of Neurophysiologic Changes in Individuals with Parkinson''''s Disease, at Risk for Parkinson''''s Disease and Healthy Controls

Further Study Details: 

Expected Total Enrollment:  600

Study start: May 2003

One of the greatest challenges in Parkinson’s research is the identification of individuals who are at risk or have early Parkinson’s disease (PD) or parkinsonian syndrome (PS). Subtle signs that do not meet the diagnostic criteria for PD may occur during this period.

This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions.

In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson’s disease or parkinsonian syndrome.

Each study participant will be scheduled for a 90 minute study visit. This visit may include the following procedures:

  • Screening for eligibility
  • Clinical assessments
  • Neurological evaluation
  • Computerized cognitive testing
  • Olfactory testing
  • Computerized handwriting testing
  • Speech evaluation
  • Blood sample for biochemical and/or genetic analysis

The study will be conducted at the Institute for Neurodegenerative Disorders (IND), which is a not for profit research institute specializing in Parkinson’s disease research.

Clinical data will be collected, stored and analyzed at IND to evaluate whether there are significant differences between the performance of the parkinsonian study participants, individuals with risk factors for PD or PS, and the healthy subjects.

Eligibility

Ages Eligible for Study:  22 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

As a participant with PD or PS:

For Healthy Control:

  • Age >21

Exclusion Criteria:

As a participant with PD or PS:

  • Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks tested in this study (e.g. stroke, demyelinating disease, visual loss)

For Healthy Control:

  • Any indication of parkinsonism on examination
  • Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks (e.g. stroke, demyelinating disease, visual loss)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00117195


Connecticut
      Institute for Neurodegenerative Disorders, New Haven,  Connecticut,  06510,  United States; Recruiting
Barbara Fussell, RN  203-401-4300    bfussell@indd.org 
Christopher Meehan, MA  203-401-4300    cmeehan@indd.org 
Kenneth Marek, MD,  Principal Investigator
Rowena Tabamo, MD,  Sub-Investigator
Danna Jennings, MD,  Sub-Investigator

Study chairs or principal investigators

Kenneth L Marek, MD,  Principal Investigator,  Institute for Neurodegenerative Disorders   
Rowena Tabamo, MD,  Study Director,  Institute for Neurodegenerative Disorders   

More Information

Publications

Blandini F, Mangiagalli A, Cosentino M, Marino F, Samuele A, Rasini E, Fancellu R, Martignoni E, Riboldazzi G, Calandrella D, Frigo GM, Nappi G. Peripheral markers of apoptosis in Parkinson''''s disease: the effect of dopaminergic drugs. Ann N Y Acad Sci. 2003 Dec;1010:675-8.

Critchley EM. Speech disorders of Parkinsonism: a review. J Neurol Neurosurg Psychiatry. 1981 Sep;44(9):751-8. Review.

Darley FL, Aronson AE, Brown JR. Clusters of deviant speech dimensions in the dysarthrias. J Speech Hear Res. 1969 Sep;12(3):462-96. No abstract available.

Koller WC, Montgomery EB. Issues in the early diagnosis of Parkinson''''s disease. Neurology. 1997 Jul;49(1 Suppl 1):S10-25. Review.

Lees AJ, Smith E. Cognitive deficits in the early stages of Parkinson''''s disease. Brain. 1983 Jun;106 (Pt 2):257-70.

Logemann JA, Fisher HB, Boshes B, Blonsky ER. Frequency and cooccurrence of vocal tract dysfunctions in the speech of a large sample of Parkinson patients. J Speech Hear Disord. 1978 Feb;43(1):47-57.

Pillon B, Ertle S, Deweer B, Bonnet AM, Vidailhet M, Dubois B. Memory for spatial location in ''''de novo'''' parkinsonian patients. Neuropsychologia. 1997 Mar;35(3):221-8.

Pirozzolo FJ, Hansch EC, Mortimer JA, Webster DD, Kuskowski MA. Dementia in Parkinson disease: a neuropsychological analysis. Brain Cogn. 1982 Jan;1(1):71-83.

Polymeropoulos MH, Lavedan C, Leroy E, Ide SE, Dehejia A, Dutra A, Pike B, Root H, Rubenstein J, Boyer R, Stenroos ES, Chandrasekharappa S, Athanassiadou A, Papapetropoulos T, Johnson WG, Lazzarini AM, Duvoisin RC, Di Iorio G, Golbe LI, Nussbaum RL. Mutation in the alpha-synuclein gene identified in families with Parkinson''''s disease. Science. 1997 Jun 27;276(5321):2045-7.

Tetrud JW. Preclinical Parkinson''''s disease: detection of motor and nonmotor manifestations. Neurology. 1991 May;41(5 Suppl 2):69-71; discussion 72.

Study ID Numbers:  Neurophysiologic
Record last reviewed:  June 2005
Last Updated:  July 1, 2005
Record first received:  July 1, 2005
ClinicalTrials.gov Identifier:  NCT00117195
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05

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December 4, 2009



Page Updated: October 15, 2009
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