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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DC016656 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Boston University | OTHER |
| VA Puget Sound Health Care System | FED |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The Investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in Parkinson's disease. The Investigators will administer speech tasks and cognitive assessments to participants with Parkinson's disease and healthy controls. The Investigators will also explore the associations between genetic factors and speech and cognitive status in Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease | Subjects with Parkinson's Disease |
| |
| Control | Subjects without Parkinson's Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Battery | Diagnostic Test | Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mild Cognitive Impairment | Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria | baseline |
| Mean Fundamental Frequency | These acoustic measures during spontaneous speech (picture description) were calculated using Praat | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls
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| Name | Affiliation | Role |
|---|---|---|
| Kara Smith, MD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School/UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson's Disease | Participants with Parkinson's Disease with Mild Cognitive Impairment or normal cognitive function |
| FG001 | Control | Neurotypical controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population is the same as the assignment information, all enrolled participants were analyzed. One participant could not be appropriately categorized into the cognitive subgroups, thus the number of participants with cognitive categorization was 48.
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson's Disease | Subjects with Parkinson's Disease |
| BG001 | Control | Subjects without Parkinson's Disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mild Cognitive Impairment | Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria | The entire baseline cohort was analyzed (n=49). Per pre-specified exclusion criteria, one participant determined to have dementia (n=1) was excluded from outcome measure analysis reporting, thus the outcome measure data represents n=48 participants. | Posted | Count of Participants | Participants | baseline |
|
This was a single visit, cross-sectional study. Adverse event data was collected during the single half-day study visit only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson's Disease | Subjects with Parkinson's Disease | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Smith, MD | University of Massachusetts Medical School | 5083342527 | kara.smith@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2020 | Apr 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2021 | Apr 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D013060 | Speech |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014831 | Voice |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| Massachusetts Institute of Technology |
| OTHER |
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Blood samples
| Voice, Speech and Language Analysis | Behavioral | Participants will be asked to perform speaking and reading tasks, which will be recorded. Participants will be asked to complete a laptop-based test of language comprehension. |
|
| Questionnaires and Clinical Assessments | Behavioral | Participants with Parkinson's disease will complete an examination of their symptoms and questionnaires assessing disease symptoms, mood and activities of daily living. Healthy controls participants will be asked to complete questionnaires on mood. |
|
| DNA Analysis | Genetic | Participants will have their blood drawn for DNA analysis. |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Mild cognitive impairment | MCI in Parkinson's disease participants according to MDS Task Force Level II Criteria | Count of Participants | Participants |
|
| Mean fundamental frequency | This acoustic measure is related to average pitch of voice. It was measured using Praat software during picture description task, in all participants. | Mean | Standard Deviation | hz |
|
| OG001 | Control | Subjects without Parkinson's Disease Cognitive Battery: Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities). Voice, Speech and Language Analysis: Participants will be asked to perform speaking and reading tasks, which will be recorded. Participants will be asked to complete a laptop-based test of language comprehension. Questionnaires and Clinical Assessments: Participants with Parkinson's disease will complete an examination of their symptoms and questionnaires assessing disease symptoms, mood and activities of daily living. Healthy controls participants will be asked to complete questionnaires on mood. |
|
|
| Primary | Mean Fundamental Frequency | These acoustic measures during spontaneous speech (picture description) were calculated using Praat | same as enrolled | Posted | Mean | Standard Deviation | Hz | baseline |
|
|
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| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Control | Subjects without Parkinson's Disease | 0 | 9 | 0 | 9 | 0 | 9 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |