Trial Outcomes & Findings for Speech, Linguistic and Acoustic Markers in Parkinson's Disease (NCT NCT04273672)
NCT ID: NCT04273672
Last Updated: 2025-06-10
Results Overview
Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria
Recruitment status
COMPLETED
Target enrollment
58 participants
Primary outcome timeframe
baseline
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Parkinson's Disease
Participants with Parkinson's Disease with Mild Cognitive Impairment or normal cognitive function
|
Control
Neurotypical controls
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
9
|
|
Overall Study
COMPLETED
|
49
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Speech, Linguistic and Acoustic Markers in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Parkinson's Disease
n=49 Participants
Subjects with Parkinson's Disease
|
Control
n=9 Participants
Subjects without Parkinson's Disease
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Mild cognitive impairment
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Mean fundamental frequency
|
137.9 hz
STANDARD_DEVIATION 37.7 • n=5 Participants
|
166.4 hz
STANDARD_DEVIATION 29.7 • n=7 Participants
|
142.3 hz
STANDARD_DEVIATION 36.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 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.
Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria
Outcome measures
| Measure |
Parkinson's Disease
n=49 Participants
Subjects with 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.
DNA Analysis: Participants will have their blood drawn for DNA analysis.
|
Control
n=9 Participants
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.
|
Controls
Neurotypical controls without neurological disorder
|
|---|---|---|---|
|
Mild Cognitive Impairment
Parkinson's disease with mild Cognitive Impairment
|
25 Participants
|
0 Participants
|
—
|
|
Mild Cognitive Impairment
Parkinson's disease with normal cognition
|
23 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: baselinePopulation: same as enrolled
These acoustic measures during spontaneous speech (picture description) were calculated using Praat
Outcome measures
| Measure |
Parkinson's Disease
n=25 Participants
Subjects with 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.
DNA Analysis: Participants will have their blood drawn for DNA analysis.
|
Control
n=23 Participants
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.
|
Controls
n=9 Participants
Neurotypical controls without neurological disorder
|
|---|---|---|---|
|
Mean Fundamental Frequency
|
137.7 Hz
Standard Deviation 39.6
|
142.4 Hz
Standard Deviation 39.6
|
166.4 Hz
Standard Deviation 29.7
|
Adverse Events
Parkinson's Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kara Smith, MD
University of Massachusetts Medical School
Phone: 5083342527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place