Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 3:54 AM
Study NCT ID:
NCT00117195
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "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."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['parkinson', 'diagnosis', 'screening'], 'conditions': ["Parkinson's Disease", 'Parkinsonian Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '15033810', 'type': 'BACKGROUND', 'citation': "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': '11262703', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7031185', 'type': 'BACKGROUND', 'citation': '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': '5811846', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '9222271', 'type': 'BACKGROUND', 'citation': "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': '6850270', 'type': 'BACKGROUND', 'citation': "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': '2927680', 'type': 'BACKGROUND', 'citation': "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': '633872', 'type': 'BACKGROUND', 'citation': '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': '9051671', 'type': 'BACKGROUND', 'citation': "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': '6927555', 'type': 'BACKGROUND', '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. doi: 10.1016/0278-2626(82)90007-0.'}, {'pmid': '9197268', 'type': 'BACKGROUND', '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. doi: 10.1126/science.276.5321.2045."}, {'type': 'BACKGROUND', 'citation': "Ramig LO. (1993) Speech therapy for patients with Parkinson's disease. NCVS Status Prog Rep 5:83-90."}, {'pmid': '2041596', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nSpecifically, 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.", 'detailedDescription': "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.\n\nThis 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.\n\nIn 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.\n\nEach study participant will be scheduled for a 90 minute study visit.\n\nThis visit may include the following procedures:\n\n* Screening for eligibility\n* Clinical assessments\n* Neurological evaluation\n* Computerized cognitive testing\n* Olfactory testing\n* Computerized handwriting testing\n* Speech evaluation\n* Blood sample for biochemical and/or genetic analysis\n\nThe 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.\n\nClinical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAs a participant with PD or PS:\n\n* Age \\>21\n* 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\n\nFor Healthy Control:\n\n* Age \\>21\n\nExclusion Criteria:\n\nAs a participant with PD or PS:\n\n* 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)\n\nFor Healthy Control:\n\n* Any indication of parkinsonism on examination\n* 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)'}, 'identificationModule': {'nctId': 'NCT00117195', 'briefTitle': "A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Institute for Neurodegenerative Disorders'}, 'officialTitle': "Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls", 'orgStudyIdInfo': {'id': 'Neurophysiologic'}, 'secondaryIdInfos': [{'id': 'Neurophys', 'type': 'OTHER', 'domain': 'MNI/IND'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD/PS', 'interventionNames': ['Device: Automated Neuropsychological Assessment Matrix']}], 'interventions': [{'name': 'Automated Neuropsychological Assessment Matrix', 'type': 'DEVICE', 'description': "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.\n\nIn 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.", 'armGroupLabels': ['PD/PS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Kenneth L Marek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}, {'name': 'Laura Leary', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}, 'collaborators': [{'name': 'Molecular NeuroImaging', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kenneth Marek, MD', 'investigatorAffiliation': 'Institute for Neurodegenerative Disorders'}}}}