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
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 620
Study Start Date: May 2003
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117195

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Investigators
Principal Investigator: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
Study Director: Laura Leary Institute for Neurodegenerative Disorders
  More Information

Publications:
Agid Y, Javoy-Agid, Ruberg M. Biochemistry of neurotransmitters in Parkinson's disease. In: Marsden CD, Fahn S, eds. Movement Disorders 2: neurology, vol 7. London: Butterworths, pp 166-230.
Brin MF, Fahn S, Blitzer A, Ramig LO, Stewart CF. (1992) Movement disorders of the larynx. In: Blitzer AA, Brin MF, Fahn S, Sasaki CT Harris K eds. Neurological disorders of the larynx. New York: Thieme Medical, pp 248-78.
Fahn S. (1986) Parkinson's disease and other basal ganglia disorders. In Asbiry AK, Mchann GM, McDonald WI, eds. Diseases of the nervous system: clinical neurobiology. Philadelphia: Ardmore Medical Books, pp1217-1228.
Levin BE, Labre MM, Weiner WJ. Cognitive impairment associated with early Parkinson's disease. Neurology 39:557-561, 1989.
Ramig LO. (1993) Speech therapy for patients with Parkinson's disease. NCVS Status Prog Rep 5:83-90.

Responsible Party: Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00117195     History of Changes
Other Study ID Numbers: Neurophysiologic, Neurophys
Study First Received: June 30, 2005
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
diagnosis
screening

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 22, 2014