NCT04273672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

February 12, 2020

Results QC Date

April 17, 2025

Last Update Submit

June 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Parkinson's Disease

Subjects with Parkinson's Disease

Diagnostic Test: Cognitive BatteryBehavioral: Voice, Speech and Language AnalysisBehavioral: Questionnaires and Clinical AssessmentsGenetic: DNA Analysis

Control

Subjects without Parkinson's Disease

Diagnostic Test: Cognitive BatteryBehavioral: Voice, Speech and Language AnalysisBehavioral: Questionnaires and Clinical Assessments

Interventions

Cognitive BatteryDIAGNOSTIC_TEST

Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).

ControlParkinson's Disease

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.

ControlParkinson's Disease

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.

ControlParkinson's Disease

Participants will have their blood drawn for DNA analysis.

Parkinson's Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls

You may qualify if:

  • Parkinson's Disease (or healthy control)
  • Disease duration ≥ 2 years
  • Mild cognitive impairment or normal cognition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionSpeech

Interventions

VoiceSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Kara Smith, MD
Organization
University of Massachusetts Medical School

Study Officials

  • Kara Smith, MD

    UMass Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 18, 2020

Study Start

January 13, 2020

Primary Completion

September 1, 2023

Study Completion

February 28, 2025

Last Updated

June 10, 2025

Results First Posted

June 10, 2025

Record last verified: 2025-06

Locations