Skip to main content
OpenTrials
Completed

NCT Number: NCT00117195

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Automated Neuropsychological Assessment Matrix

Device

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.

Sponsors and collaborators

Lead sponsor

Institute for Neurodegenerative Disorders

Other

Collaborators

  • Molecular NeuroImaging

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2012
First posted
Jul 4, 2005
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.