Parkinson DiseaseSLAM-PDNCT04273672
Speech, Linguistic and Acoustic Markers in Parkinson's Disease
An observational study of Parkinson Disease and Cognitive Impairment, Mild, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Cognitive Impairment, Mild, Speech
- What is being tested?
- Cognitive Battery, Voice, Speech and Language Analysis and Questionnaires and Clinical Assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 28 Feb 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls
Who may be able to join
- Parkinson's Disease (or healthy control)
- Disease duration ≥ 2 years
- Mild cognitive impairment or normal cognition
Who cannot join
- Diagnosis of dementia (MoCA <21)
- Adults unable to consent
- Age < 18
- Pregnant women
- Prisoners
- Non-English speakers
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School/UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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.
- Conditions
- Parkinson Disease, Cognitive Impairment, Mild, Speech
- Being tested
- Cognitive Battery, Voice, Speech and Language Analysis, Questionnaires and Clinical Assessments, DNA Analysis
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive BatteryDiagnostic test
Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).
Voice, Speech and Language AnalysisBehavioural
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 AssessmentsBehavioural
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 AnalysisGenetic
Participants will have their blood drawn for DNA analysis.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Subjects with Parkinson's Disease Receives: Diagnostic Test: Cognitive Battery; Behavioral: Voice, Speech and Language Analysis; Behavioral: Questionnaires and Clinical Assessments; Genetic: DNA Analysis | |
| Control | Subjects without Parkinson's Disease Receives: Diagnostic Test: Cognitive Battery; Behavioral: Voice, Speech and Language Analysis; Behavioral: Questionnaires and Clinical Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mild Cognitive Impairment
Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria
Measured: baseline
Mean Fundamental Frequency
These acoustic measures during spontaneous speech (picture description) were calculated using Praat
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start13 Jan 2020
- Primary completion1 Sep 2023
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, VA Puget Sound Health Care System, National Institute on Deafness and Other Communication Disorders (NIDCD), Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Kara Smith, University of Massachusetts, Worcester
- Investigators
- Kara Smith, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273672
- Sponsor's protocol ID
- H00011523
- Other IDs
- 5K23DC016656
- Acronym
- SLAM-PD
- Status last verified
- Jun 2025
- First submitted
- 12 Feb 2020
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech, Linguistic and Acoustic Markers in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04273672
- Acronym / sponsor ID
- SLAM-PD / H00011523
- Conditions
- Parkinson Disease, Cognitive Impairment, Mild, Speech
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Boston University, VA Puget Sound Health Care System, National Institute on Deafness and Other Communication Disorders (NIDCD), Massachusetts Institute of Technology
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Diagnostic Test: Cognitive Battery, Behavioral: Voice, Speech and Language Analysis, Behavioral: Questionnaires and Clinical Assessments, Genetic: DNA AnalysisSubjects with Parkinson's Disease |
| Control | – | Diagnostic Test: Cognitive Battery, Behavioral: Voice, Speech and Language Analysis, Behavioral: Questionnaires and Clinical AssessmentsSubjects without Parkinson's Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls
Key inclusion criteria (3 listed)
- Parkinson's Disease (or healthy control)
- Disease duration ≥ 2 years
- Mild cognitive impairment or normal cognition
Key exclusion criteria (12 listed)
- Diagnosis of dementia (MoCA <21)
- Adults unable to consent
- Age < 18
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Cognitive BatteryParticipants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities). | Diagnostic test | Control, Parkinson's Disease |
| Voice, Speech and Language AnalysisParticipants 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. | Behavioural | Control, Parkinson's Disease |
| Questionnaires and Clinical AssessmentsParticipants 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. | Behavioural | Control, Parkinson's Disease |
| DNA AnalysisParticipants will have their blood drawn for DNA analysis. | Genetic | Parkinson's Disease |
Primary outcome
Mild Cognitive Impairment
Time frame: baseline
Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria
Mean Fundamental Frequency
Time frame: baseline
These acoustic measures during spontaneous speech (picture description) were calculated using Praat
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Kara Smith, MD principal investigator
UMass Medical School
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 Disease and Cognitive Impairment, Mild, run by University of Massachusetts, Worcester 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 3 inclusion and 12 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 10 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Mild Cognitive Impairment (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.