Speech, Linguistic and Acoustic Markers in Parkinson's Disease

Parkinson Disease Clinical Trial

— SLAM-PD  

Official title:

Speech, Linguistic and Acoustic Markers in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04273672
• Other study ID #: H00011523
• Secondary ID: 5K23DC016656
• Status: Active, not recruiting
• Start date: January 13, 2020
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The Investigators will also explore the associations between genetic factors and speech and cognitive status in Parkinson's disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: February 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Parkinson Disease
• Speech

Intervention

Diagnostic Test:
• Cognitive Battery
Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).

Behavioral:
• 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.

Genetic:
• DNA Analysis
Participants will have their blood drawn for DNA analysis.

Locations

Country	Name	City	State
United States	UMass Medical School/UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Boston University, Massachusetts Institute of Technology, Lincoln Laboratories, National Institute on Deafness and Other Communication Disorders (NIDCD), VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of speech acoustic parameters that classify PD participants by cognitive status (mild cognitive impairment [MCI] vs. normal cognition)	Gaussian regression modeling and other machine learning techniques will be used to develop a model including fundamental frequency, noise-to-harmonic ratio, cepstral peak prominence, formants, phoneme-dependent speaking rates and diadochokinesis rate and quality to predict categorization of PD participants by disease and cognitive status.	12-24 months
Primary	Duration and location of pauses during speech in PD participants with and without mild cognitive impairment	Participants will produce speech samples of spontaneous speech, which will be transcribed and coded for pause length and location, and these characteristics will be entered into a non-linear mixed model with the three-level predictor of group membership (control, PD-MCI, PD with normal cognition) as the parameter of interest.	12-24 months
Primary	Syntax processing efficiency score (percentage correctly understood sentences/processing time) in controls, and in PD with and without MCI	When presented with sentences of varying syntactical complexity in a self-paced task, participants response time and accuracy will be used to create multilevel models and test for effect of group (controls, PD, PD-MCI).	12-24 months