An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Nearly 90% of people with Parkinson's disease have speech and voice disorders that negatively impact their ability to communicate effectively in daily life. This study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with Parkinson's disease and speech impairment. This approach would offer an affordable way to continue to both instruct and encourage training by Veterans virtually indefinitely through the remote access technology. These findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and speech impairment.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Combined speech and exercise intervention; Behavioral: Health education

Detailed Description

Background/Rationale The great majority of individuals with Parkinson's disease (PD) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. Hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). Changes in speech may appear early in PD and progress in severity over time. Further, such changes in speech lead to significant declines in functional communication and quality of life. Pharmacological and surgical interventions that alleviate motor symptoms in PD are largely ineffective or sometimes even detrimental for speech.

Objectives Based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in PD to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. The investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program.

Methods A total of 104 community-dwelling Veterans with hypokinetic dysarthria in mild-to-moderate PD will be randomly assigned to the exercise intervention or to the health education control. The investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niquel Ortega; Phone Number: (857) 364-5669; Email: Niquel.Ortega@va.gov

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • Recruiting
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
      • Principal Investigator: David William Sparrow, DSc
      • Contact: Niquel Ortega; Phone Number: (857) 364-5669; Email: Niquel.Ortega@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physician diagnosis of idiopathic Parkinson's disease (PD)
• At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
• Response to dopaminergic medication
• Hypokinetic dysarthria

Exclusion Criteria:

• Angina pectoris
• History of myocardial infarction (MI) within 6 months
• History of ventricular dysrhythmia requiring current therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Health education	Behavioral: Health education; Provision of general information about a variety of topics
Experimental: Combined speech and exercise intervention; Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.	Behavioral: Combined speech and exercise intervention; Home-based exercise intervention with interactive automated speech response features

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Intelligibility	Change in speech intelligibility from baseline to 6-month follow-up is the outcome, which will be based on analysis of acoustic recordings.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: David William Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's disease; Dysarthria; Speech therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Language Disorders; Communication Disorders; Speech Disorders; Articulation Disorders; Parkinson Disease; Dysarthria
• Other Study ID Numbers: E3378-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No