Cognitive Impairment, Mild, Parkinson Disease, Speech
Conditions
Brief summary
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.
Interventions
BEHAVIORALVoice, 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.
DIAGNOSTIC_TESTCognitive Battery
Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).
BEHAVIORALQuestionnaires 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.
GENETICDNA Analysis
Participants will have their blood drawn for DNA analysis.
Sponsors
Boston University
VA Puget Sound Health Care System
National Institute on Deafness and Other Communication Disorders (NIDCD)
Massachusetts Institute of Technology/Lincoln Labs
University of Massachusetts, Worcester
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parkinson's Disease (or healthy control) * Disease duration ≥ 2 years * Mild cognitive impairment or normal cognition
Exclusion criteria
* Diagnosis of dementia (MoCA \<21) * Adults unable to consent * Age \< 18 * Pregnant women * Prisoners * Non-English speakers * Any neurological disorder other than PD * Deep brain stimulator placement * Severe, unstable psychiatric disorder * Unintelligible speech due to effects of PD * Visual acuity or color vision impairment that would interfere with cognitive testing * Other voice, speech or swallowing disorders or history of surgery involving palate/nasopharynx/larynx/vocal cords
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mild Cognitive Impairment | baseline | Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria |
| Mean Fundamental Frequency | baseline | These acoustic measures during spontaneous speech (picture description) were calculated using Praat |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parkinson's Disease Subjects with Parkinson's Disease | 49 |
| Control Subjects without Parkinson's Disease | 9 |
| Total | 58 |
Baseline characteristics
| Characteristic | Total | Control | Parkinson's Disease |
|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 7.3 | 67.0 years STANDARD_DEVIATION 11.8 | 67.9 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 9 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean fundamental frequency | 142.3 hz STANDARD_DEVIATION 36.5 | 166.4 hz STANDARD_DEVIATION 29.7 | 137.9 hz STANDARD_DEVIATION 37.7 |
| Mild cognitive impairment | 25 Participants | 0 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 9 Participants | 47 Participants |
| Sex: Female, Male Female | 23 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 35 Participants | 2 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 9 |
| other Total, other adverse events | 0 / 49 | 0 / 9 |
| serious Total, serious adverse events | 0 / 49 | 0 / 9 |
Outcome results
Primary
Mean Fundamental Frequency
These acoustic measures during spontaneous speech (picture description) were calculated using Praat
Time frame: baseline
Population: same as enrolled
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Mean Fundamental Frequency | 137.7 Hz | Standard Deviation 39.6 |
| Control | Mean Fundamental Frequency | 142.4 Hz | Standard Deviation 39.6 |
| Controls | Mean Fundamental Frequency | 166.4 Hz | Standard Deviation 29.7 |
Primary
Mild Cognitive Impairment
Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria
Time frame: baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parkinson's Disease | Mild Cognitive Impairment | Parkinson's disease with mild Cognitive Impairment | 25 Participants |
| Parkinson's Disease | Mild Cognitive Impairment | Parkinson's disease with normal cognition | 23 Participants |
| Control | Mild Cognitive Impairment | Parkinson's disease with mild Cognitive Impairment | 0 Participants |
| Control | Mild Cognitive Impairment | Parkinson's disease with normal cognition | 9 Participants |