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A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00117195
First received: June 30, 2005
Last updated: February 8, 2012
Last verified: February 2012

June 30, 2005
February 8, 2012
May 2003
January 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00117195 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.

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

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.

PD/PS
Intervention: Device: Automated Neuropsychological Assessment Matrix

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
620
January 2012
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

As a participant with PD or PS:

  • Age >21
  • Clinical diagnosis of PD or PS (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) and a clinical response to dopaminergic therapy

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)
Both
22 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00117195
Neurophysiologic, Neurophys
Yes
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Principal Investigator: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
Study Director: Laura Leary Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP