Effects of Neuromuscular Electrical Stimulation in Patients with Post-Stroke Related Dysarthria: A Double-Blinded, Phase-II Randomized Sham-Controlled Trial Protocol - ULYSSES Trial
Authors:   Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, Dodurgali Mustafa Reha ,   Principles and Practice of Clinical Research (PPCR), Harvard T.H. Chan School of Public Health - ECPE, Boston, MA, USA, Coll-Fernández Roser ,   Department of Rehabilitation, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, Queiroz Petrus Fernanda ,   Pontifícia Universidade Católica do Paraná (PUCPR), Londrina Brazil, Kawano Márcio ,   Clinical Oncology, São Camilo Mooca (IBCC Oncologia) and Hospital da Santa Casa de São Paulo, São Paulo, Brazil, Schreiber Franziska ,   Institute of Pathology, Ludwig-Maximilians-University Munich, Germany, de Lima Froio Nayara ,   State Government Employee Medical Assistance Institute (IAMSPE) and Federal University of São Paulo (UNIFESP), São Paulo, Brazil, Machado Lacerda Guilherme Jose ,   Universidade de São Paulo (HC-FMUSP), São Paulo, Brazil, Lopez Edilin ,   Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, MA, USA, Martins Adrielly ,   Hospital Cárdio Pulmonar and Hospital Aliança - Rede D’Or São Luiz, Salvador, Bahia, Brazil, Flores- Flores Angélica ,   Laboratory of Immunopharmacology, Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas", Mexico City, Mexico, Machado Belen ,   Clinical Pharmacology Department, University of Sabana, Bogotá, Colombia, Soares dos Santos Bethânia ,   Clinical Oncology, Rede D’Or Rio de Janeiro, Brazil, Parron Bianca ,   Pontifícia Universidade Católica do Paraná (PUCPR), Londrina Brazil, Tapia Argudo Christiany Marilinn ,   Department of Cardiovascular, Internal Medicine, YALE Cardiovascular Research Group, New Haven, CT, USA, dos Santos Barros Claudia Renata ,   Butantan Institute, São Paulo, Brazil, Stephan Cristina ,   Step Medical Affairs Consulting, São Paulo, Brazil, Bouzas Rodeiro Daniela ,   Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil, Mucci Gustavo ,   Retina Department, Evangelico Hospital and Luvere Clinic, Belo Horizonte, Brazil, Carvajal Acosta James Alfonso ,   Fundacion Clinica Abood Shaio (FCS), Surgery Department, Bogotá, Colombia, Rabelo Laporte Larrie ,   Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil, De Leon Benedetti Laura ,   Children’s Hospital of Philadelphia, Philadelphia, PA, USA, Morales Ojeda Luis ,   Department of Female Pelvic Medicine and Reconstructive Surgery, Institute of Urology, Keck School of Medicine USC, Los Angeles, CA, USA, Raso Bastos Paula ,   Dermatology, IRDA Santa Casa RJ, Rio de Janeiro, Brazil, Villalobos Regina ,   Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA, Trindade Gomes da Silva Vinicius ,   Division of Neurosurgery, University of Sao Paulo Medical School, São Paulo, Brazil, Haseeb Abdul ,   Department of Clinical Pharmacy, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia, Gasparoto Pereira Valério Mariana ,   Hôpitaux Universitaires de Genève, Service des Maladies Infectieuses, Unité VIH/SIDA, Geneva, Switzerland, Moll-Bernardes Renata Junqueira ,   D’Or Institute for Research and Education, Rio de Janeiro, Brazil, Ferreira de Freitas Euzébio Roseanne ,   Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada, Rangel Olivera Gabriel ,   Hospital General ISSSTE Tláhuac, Mexico City, Mexico, dos Santos Kasai Caio Cesar ,   Pontifícia Universidade Católica do Paraná (PUCPR), Londrina Brazil, Minisha Fathima ,   Women’s Wellness and Research Centre, Hamad Medical Corporation, Doha, Qatar, Silva Godinez Juan Carlos ,   Hospital de Oncología, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
Published: August 2023

Introduction: Post-stroke individuals with dysarthria experience difficulties in producing speech due to muscle dysfunction. Neuromuscular electrical stimulation (NMES) can stimulate motor units and enhance their functionality. The objective of this study is to investigate the effects of NMES on speech intelligibility in patients with persistent dysarthria 3-6 months post-ischemic stroke. Methods: This study will be designed as a phase II, double-blinded, randomized, two-arm, parallel-group, superiority trial conducted at a single center. The target population will consist of post-stroke individuals with dysarthria, who will undergo randomization to receive either neuromuscular electrical stimulation (NMES) or sham-NMES. Both intervention groups will receive treatment sessions 5 days a week over a 4-week period. The sample size for this study will be 154 patients, recruited exclusively from a Rehabilitation Unit located in the United States. The primary outcome measure will focus on determining the mean difference in the FDA-2 intelligibility score between the two treatment groups. Secondary outcomes will involve evaluating the mean difference in the full FDA-2 score, as well as various subsets of the score, alongside an assessment of the participants’ health-related quality of life, utilizing the Stroke Impact Scale (SIS). Conclusion: To the best of our knowledge, this will be a comprehensive assessment of the potential benefits of NMES for post- stroke patients with dysarthria. Considering the positive impact of NMES on enhancing muscle functionality, it is plausible to anticipate its potential benefits in improving speech outcomes as well. Despite early studies indicating the safety and tolerability of NMES for various motor muscle conditions, there is limited data on its use in patients with dysarthria.