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

February 8, 2012 updated by: Kenneth Marek, MD, Institute for Neurodegenerative Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD/PS
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

Molecular NeuroImaging

Investigators

  • Study Director: Laura Leary, Institute for Neurodegenerative Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 4, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurophysiologic
  • Neurophys (Other Identifier: MNI/IND)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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