An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Parkinson's Disease Clinical Trial

Official title:

An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617496
• Other study ID #: E3378-R
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Niquel Ortega
• Phone: (857) 364-5669
• Email: Niquel.Ortega[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: April 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysarthria
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Combined speech and exercise intervention
Home-based exercise intervention with interactive automated speech response features
• Health education
Provision of general information about a variety of topics

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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