Parkinson's DiseaseNCT00117195
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
An observational study of Parkinson's Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinsonian Syndrome
- What is being tested?
- Automated Neuropsychological Assessment Matrix
- Type of treatment
- Medical device
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls
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.
Read the 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.
- Conditions
- Parkinson's Disease, Parkinsonian Syndrome
- Being tested
- Automated Neuropsychological Assessment Matrix
- Keywords
- parkinson, diagnosis, screening
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Neuropsychological Assessment MatrixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PD/PS | Not described Receives: Device: Automated Neuropsychological Assessment Matrix |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2005 (estimated)
- Study startMay 2003
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular NeuroImaging
- Responsible party
- Principal investigator, Kenneth Marek, MD, Institute for Neurodegenerative Disorders
- Investigators
- Kenneth L Marek, MD, Principal investigator, Institute for Neurodegenerative DisordersLaura Leary, Study director, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117195
- Sponsor's protocol ID
- Neurophysiologic
- Other IDs
- Neurophys
- Status last verified
- Feb 2012
- First submitted
- 30 Jun 2005
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
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.
PubMed 15033810Bleiberg 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.
PubMed 11262703Brin 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.
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.
PubMed 7031185Darley 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.
PubMed 5811846Fahn 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.
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.
PubMed 9222271Lees 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.
PubMed 6850270Levin 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.
PubMed 2927680Logemann 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.
PubMed 633872Pillon 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.
PubMed 9051671Pirozzolo 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.
PubMed 6927555Polymeropoulos 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.
PubMed 9197268Ramig LO. (1993) Speech therapy for patients with Parkinson's disease. NCVS Status Prog Rep 5:83-90.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT00117195
- Acronym / sponsor ID
- Neurophysiologic
- Conditions
- Parkinson's Disease, Parkinsonian Syndrome
- Keywords
- parkinson, diagnosis, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Collaborators
- Molecular NeuroImaging
- Study start
- May 2003
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD/PS | – | Device: Automated Neuropsychological Assessment Matrix |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.
Key inclusion criteria (5 listed)
- 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
- Age >21
Key exclusion criteria (5 listed)
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Neuropsychological Assessment MatrixThis 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. | Device | PD/PS |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- BackgroundAgid 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: PubMed 15033810Blandini 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.
- Background: PubMed 11262703Bleiberg 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.
- BackgroundBrin 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: PubMed 7031185Critchley EM. Speech disorders of Parkinsonism: a review. J Neurol Neurosurg Psychiatry. 1981 Sep;44(9):751-8. doi: 10.1136/jnnp.44.9.751.
- Background: PubMed 5811846Darley 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.
- BackgroundFahn 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: PubMed 9222271Koller 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.
- Background: PubMed 6850270Lees 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.
- Background: PubMed 2927680Levin 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.
- Background: PubMed 633872Logemann 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.
- Background: PubMed 9051671Pillon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth L Marek, MD principal investigator
Institute for Neurodegenerative Disorders
Laura Leary study director
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117195, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.