REhabilitation of Dysphagia with ACupuncture and Auricular Therapy after Severe Acquired Brain Injury (REDACT Study): A Double-Blind Randomized Controlled Trial Protocol

Martina Calamini¹Agnese De Nisco^2*Francesca Draghi²FRANCESCA CECCHI^2,3Paola Graziani^2,4Antonello Grippo^2,5Claudio Macchi²Daniela Maccanti²Annamaria Romoli²Silvia Pancani²Carmelo Pasquale Guido⁶Bahia Hakiki^2,3

• ¹School of Specialization in Physical and Rehabilitation Medicine, University of Florence, Florence, Italy
• ²Centro IRCCS Don Gnocchi, Florence, Italy
• ³Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
• ⁴Head and Neck and Robotic Surgery, Azienda Ospedaliero Universitaria Careggi, Florence, Italy
• ⁵SODc Neurophysiopathology, Department Neuromuscolo-Scheletrico e degli Organi di Senso, Azienda Ospedaliero Universitaria Careggi, Florence, Italy
• ⁶Regional Reference Center for Traditional Chinese Medicine, Corporate Coordination Center for Complementary Medicine, Florence, Italy

Neurogenic dysphagia affects up to 99% of patients with severe acquired brain injury (sABI) upon admission to intensive rehabilitation units (IRU) and increase clinical complications, resource use, and mortality. Conventional dysphagia rehabilitation often relies on active techniques, which are hardly applicable in non-collaborative patients, as is often the case with patients after sABI. In the absence of guidelines for dysphagia rehabilitation that consider the heterogeneity and clinical complexity of these patients, acupuncture and auriculotherapy (AA) could represent a valid intervention to be introduced into clinical practice. The aim of this multicenter double-blind, randomized, controlled trial is to evaluate the superiority of AA combined with conventional rehabilitation compared to conventional rehabilitation alone in improving dysphagia in non-cooperative vascular sABI patients. To this end, improvement in swallowing will be measured using both a clinical scale (Mann Assessment of Swallowing Ability-MASA) and a fiber optic endoscopic assessment (Pooling Score). This is a provisional file, not the final typeset article Certain characteristics of patients admitted to IRUs after sABI, such as the rate and timing of decannulation, the infection rate, and the functional outcome measured by the Glasgow Outcome Scale–Extended, will also be taken into consideration as secondary outcomes. By incorporating AA therapy into a personalized rehabilitation program, this study will examine its potential clinical benefits on dysphagia and the feasibility of this approach in the setting of early intensive rehabilitation for patients with sABI. AA could represent a low-cost, accessible bedside treatment complementary to standard rehabilitation, with no adverse effects, applicable in different clinical settings and at all stages of rehabilitation. Clinical Trial Registration: NCT068882