The effect of SpeechVive device on speech intelligibility in Parkinson’s Disease patients: Randomized Clinical Trial Protocol

Main Article Content

Laura Michelle Santana Rodriguez
https://orcid.org/0000-0001-8505-3037
Amanda Marcinowska
Criscely Go
Alicia Gonzalez
https://orcid.org/0000-0002-1228-1503
Gabriela Pinto
https://orcid.org/0000-0003-3270-6393
Qiang Nai
Vasthala Juvvingunta
Oriana Escobar
Joao Pedro Lima
https://orcid.org/0000-0002-5486-7211
Enrique Bedoya-Ismodes
https://orcid.org/0000-0002-6792-2371
Mohammad Mohsin Arshad
Ana Carolina Benites
Renata Couto
Abel Perez
https://orcid.org/0000-0002-1238-3112
Andres Pavlovic
Samuel Ramos Garcia
https://orcid.org/0000-0003-3441-8387
Jaweria Akram
Jesabelle Dominguez
https://orcid.org/0000-0002-5936-8534
Luisa dos Santos
Wei Zhang
Michael Sheng-Fu Feng
Basil Alshekh
https://orcid.org/0000-0003-3880-965X
Priscila Prais Carneiro
https://orcid.org/0000-0003-1197-636X
Suellen Riccio
Daniel Urla
Ygor Junqueira
https://orcid.org/0000-0002-8534-7446
Jose Agustin Rojas
https://orcid.org/0000-0002-8572-6155
Arturo Tamayo
Elly Pichardo
Lucas Pepe Mena
Diego Daniel Garcia
Denise S Schwartz

Abstract

ABSTRACT


 


Background: Hypokinetic dysarthria -with hypophonia as its main symptom- is a common feature of Parkinson’s disease, affecting approximately 90% of patients. Hypophonia, characterized by reduced speech volume, leads to difficulties in communication with others due to decreased speech intelligibility. Current treatments involve intensive and cognitively demanding behavioral therapies such as the Lee Silverman Voice Treatment (LSVT). The SpeechVive is a wearable device that produces noise to elicit increased vocal intensity utilizing a natural reflex through the Lombard effect.
Methods: We propose a multicenter, phase III, two-armed, parallel, open-label, randomized controlled trial comparing the effectiveness of LSVT with SpeechVive. We seek to assign 238 patients to either LSVT or SpeechVive device in a 1:1 ratio through a stratified permuted block randomization. Patients ages 50 to 80 years, diagnosed with idiopathic Parkinson's Disease based on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) criteria, a Hoehn and Yahr stage 2 and 3, on stable dopaminergic doses for the past 3 months, with perceived communication difficulties will be included in the trial. Patients will be excluded if they present additional neurodegenerative diseases, prior stroke, laryngeal pathologies, hearing or a severe visual impairment, or who underwent speech therapy or have a deep brain stimulation electrode implanted. The primary outcome is speech intelligibility measured through the Speech Intelligibility Test (SIT) for windows. Secondary outcomes include adherence, the vocal intensity measured with Sound Pressure Level (SPL), Vocal Handicap Index (VIH), and Parkinson's Disease Questionary-39. We will measure each outcome at baseline and after eight weeks of treatment. Our principal statistical analysis is multiple linear regression analysis, with age, gender, site, and PD severity as covariates.
Discussion: We present a protocol for a randomized controlled trial addressing an important issue that hampers the ability of Parkinson's Disease patients to communicate effectively. We aim at exploring SpeechVive as an alternative, more accessible treatment for hypophonia in patients with Parkinson’s Disease.


 


Keywords: SpeechVive device, Lee Silverman Speech Therapy (LSVT), hypophonia, Parkinson's Disease, the Lombard effect, Speech intelligibility.

Article Details

How to Cite
Santana Rodriguez, L. M., Marcinowska, A., Go, C., Gonzalez, A., Pinto, G., Nai, Q., Juvvingunta, V., Escobar, O., Lima, J. P., Bedoya-Ismodes, E., Mohsin Arshad, M., Benites, A. C., Couto, R., Perez , A., Pavlovic, A., Ramos Garcia, S., Akram, J., Dominguez, J., dos Santos, L., Zhang, W., Feng, M. S.-F., Alshekh, B., Prais Carneiro, P., Riccio, S., Urla, D., Junqueira, Y., Rojas, J. A., Tamayo, A., Pichardo, E., Pepe Mena, L., Garcia, D. D., & Schwartz, D. S. (2022). The effect of SpeechVive device on speech intelligibility in Parkinson’s Disease patients: Randomized Clinical Trial Protocol . Principles and Practice of Clinical Research, 8(2), 9–16. https://doi.org/10.21801/ppcrj.2022.82.2
Section
Clinical Research Design
Author Biographies

Laura Michelle Santana Rodriguez, Instituto Dominicano de Estudios Virologicos, Santo Domingo, Dominican Republic.

Medical Doctor, M.D.

Amanda Marcinowska, University of Toronto, MSc Fam Med, Toronto, Canada.

MSc Fam Med

Criscely Go, Jose R. Reyes Memorial Medical Center, Manila, Philippines.

Medical Doctor, M.D. , MBAH

Alicia Gonzalez, Brigham and Women’s Hospital, Harvard Medical School, USA.

Medical Doctor, M.D.

Gabriela Pinto, Universidade de São Paulo, São Paulo, Brazil.

Medical doctor, MD

Vasthala Juvvingunta, University of Nebraska Medical Center, United States.

Medical Doctor, M.D

Oriana Escobar, Universidad de los Andes, Bogota, Colombia.

Medical Doctor, M.D.

Joao Pedro Lima, Marinha do Brasil, Rio de Janeiro, Brazil.

Medical Doctor, M.D

Enrique Bedoya-Ismodes, Universidad Peruana de Ciencias Aplicadas, Lima, Peru.

Medical Doctor, M.D.

Mohammad Mohsin Arshad, Hammad Medical Cooperation, Doha, Qatar.

MBBS, MD

Andres Pavlovic, Clinica Alemana de Santiago/ Universidad del Desarrollo, Santiago, Chile.

Medical Doctor, M.D

Samuel Ramos Garcia, Pontificia Universidad Catolica Madre y Maestra, Santiago, Dominican Republic.

Medical Doctor, M.D.

Jesabelle Dominguez, Pontificia Universidad Catolica Madre y Maestra, Santiago, Dominican Republic.

Medical Doctor, M.D.

Priscila Prais Carneiro, Faculdade de Medicina ABC, São Paulo, Brazil.

Medical doctor, MD

Jose Agustin Rojas, Instituto Tecnologico de Santo Domingo, Santo Domingo, Dominican Republic.

Medical Doctor, M.D.

Denise S Schwartz, School of Veterinary Medicine and Animal Science (FMVZ), University of Sao Paulo, Sao Paulo, Brazil.

DVM, MS, PhD

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