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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117195
• Other study ID #: Neurophysiologic
• Secondary ID: Neurophys
• Status: Completed
• Phase: N/A
• First received: June 30, 2005
• Last updated: February 8, 2012
• Start date: May 2003
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders	Molecular NeuroImaging

Country where clinical trial is conducted

United States, 

References & Publications (16)

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

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

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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. — View Citation

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. — View Citation

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. — View Citation

Ramig LO. (1993) Speech therapy for patients with Parkinson's disease. NCVS Status Prog Rep 5:83-90.

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

* Note: There are 16 references in all — Click here to view all references