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

NCT00117195 | Completed DMC

• 2 other identifiers: NeurophysiologicNeurophys
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease; Parkinsonian Syndrome

Keywords

parkinson; diagnosis; screening

Study Arms (1)

PD/PS

Device: Automated Neuropsychological Assessment Matrix

Interventions

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.

PD/PS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (16)

• 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.

  BACKGROUND

• Blandini F, Mangiagalli A, Cosentino M, Marino F, Samuele A, Rasini E, Fancellu R, Martignoni E, Riboldazzi G, Calandrella D, Frigo GM, Nappi G. Peripheral markers of apoptosis in Parkinson's disease: the effect of dopaminergic drugs. Ann N Y Acad Sci. 2003 Dec;1010:675-8. doi: 10.1196/annals.1299.123.

  PMID: 15033810 BACKGROUND

• Bleiberg J, Kane RL, Reeves DL, Garmoe WS, Halpern E. Factor analysis of computerized and traditional tests used in mild brain injury research. Clin Neuropsychol. 2000 Aug;14(3):287-94. doi: 10.1076/1385-4046(200008)14:3;1-P;FT287.

  PMID: 11262703 BACKGROUND

• 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.

  BACKGROUND

• Critchley EM. Speech disorders of Parkinsonism: a review. J Neurol Neurosurg Psychiatry. 1981 Sep;44(9):751-8. doi: 10.1136/jnnp.44.9.751.

  PMID: 7031185 BACKGROUND

• Darley FL, Aronson AE, Brown JR. Clusters of deviant speech dimensions in the dysarthrias. J Speech Hear Res. 1969 Sep;12(3):462-96. doi: 10.1044/jshr.1203.462. No abstract available.

  PMID: 5811846 BACKGROUND

• 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.

  BACKGROUND

• Koller WC, Montgomery EB. Issues in the early diagnosis of Parkinson's disease. Neurology. 1997 Jul;49(1 Suppl 1):S10-25. doi: 10.1212/wnl.49.1_suppl_1.s10.

  PMID: 9222271 BACKGROUND

• Lees AJ, Smith E. Cognitive deficits in the early stages of Parkinson's disease. Brain. 1983 Jun;106 (Pt 2):257-70. doi: 10.1093/brain/106.2.257.

  PMID: 6850270 BACKGROUND

• Levin BE, Llabre MM, Weiner WJ. Cognitive impairments associated with early Parkinson's disease. Neurology. 1989 Apr;39(4):557-61. doi: 10.1212/wnl.39.4.557.

  PMID: 2927680 BACKGROUND

• Logemann JA, Fisher HB, Boshes B, Blonsky ER. Frequency and cooccurrence of vocal tract dysfunctions in the speech of a large sample of Parkinson patients. J Speech Hear Disord. 1978 Feb;43(1):47-57. doi: 10.1044/jshd.4301.47.

  PMID: 633872 BACKGROUND

• 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. doi: 10.1016/s0028-3932(96)00091-7.

  PMID: 9051671 BACKGROUND

• 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. doi: 10.1016/0278-2626(82)90007-0.

  PMID: 6927555 BACKGROUND

• 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. doi: 10.1126/science.276.5321.2045.

  PMID: 9197268 BACKGROUND

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

  BACKGROUND

• Tetrud JW. Preclinical Parkinson's disease: detection of motor and nonmotor manifestations. Neurology. 1991 May;41(5 Suppl 2):69-71; discussion 72. doi: 10.1212/wnl.41.5_suppl_2.69.

  PMID: 2041596 BACKGROUND

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.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth L Marek, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

• Laura Leary

  Institute for Neurodegenerative Disorders

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 4, 2005
• Study Start: May 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

US (1)