Somatic and Ear Acupuncture for Dysphagia Rehabilitation and Decannulation After Severe Acquired Brain Injuries

Condition(s) studied

Investigational drug(s) / intervention(s)

Acupuncture and Auricolotherapy: Based on the patient's condition and the physiology of traditional Chinese medicine, sterile disposable acupuncture needles will be placed on selected points: Auricular: * Esophagus point * Shen Men point * Palate area/ Throat point * II and III Trigeminal branches Somatic: * 17 Triple heater (if bruxisme) * 22 Conception Vessel * 23 Conception Vessel * 3 Small Intestine * Yin Tang (if apathy) * 3 Large Intestine (if xerostomy) * 36 and 44 Stomach

Conventional logopedic rehabilitation: Patients assigned to the control arm will undergo a total of 3 hours of speech and physiotherapy rehabilitation per day from Monday to Friday, and 1 hour on Saturday. Regarding speech therapy treatment, both restorative and compensatory interventions will be applied, based on the patient's clinical condition. Compensatory approaches include postural techniques (such as adopting a flexed head posture) and swallowing techniques (e.g., supraglottic swallowing, forced swallowing, the Mendelsohn maneuver), as well as modifying the consistency of liquids and food. Restorative methods involve swallowing exercises aimed at enhancing muscular strength, resistance training, and motor training of the oral structures involved in swallowing.

Study summary

The goal of this interventional, randomized, controlled, double-blind pilot study is to assess the superiority of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, for the treatment of dysphagia in patients with severe Acquired Brain Injury (sABI) of vascular etiology, who are tracheostomized and have severe cognitive impairment, classified as Level of Cognitive Functioning (LCF) \<4 according to the LCF Scale.

The main questions this study aims to answer are:

* Does a treatment of 10 sessions of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, help reduce dysphagia, as measured by clinical and instrumental scales, and shorten the time to decannulation after 4 weeks of treatment?
* Is the obtained result maintained 3 months after the end of the rehabilitation treatment?

Researchers will compare patients receiving conventional speech therapy rehabilitation with those also undergoing 10 sessions of Acupuncture and Auriculotherapy to determine whether this ancient Chinese technique can improve dysphagia and reduce time to decannulation in patients with vascular sABI and severe cognitive impairment.

Participants will be assigned to either the Intervention Group (Acupuncture and Auriculotherapy in addition to conventional rehabilitation) or the Control Group (conventional rehabilitation only). In both groups, conventional speech therapy rehabilitation will consist of 1 hour of treatment per day. The Intervention Group will undergo additional rehabilitation treatment using specific acupuncture and auriculotherapy points.

Eligibility

Primary outcome measure(s)

• Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale — From enrollment to the end of treatment at 4 weeks and at 3 months
  The Mann Assessment of Swallowing Ability (MASA) Scale consists of 26 items. The sum of the individual scores provides a total score that categorizes dysphagia and aspiration into four levels of severity. Dysphagia severity: The highest possible score is 200. 200-178: No abnormality detected 177-168: Mild dysphagia 167-139: Moderate dysphagia Below 138: Severe dysphagia (worst possible grade) Aspiration severity: The highest possible score is 200. 200-170: No abnormality detected 169-149: Mild aspiration 148-140: Moderate aspiration Below 140: Severe aspiration (worst possible grade)
• Significant difference measured by Pooling Score, based on endoscopic landmarks and bedside parameters with relative values — From enrollment to the end of treatment at 4 weeks and at 3 months
  The Pooling Score is a clinical endoscopic evaluation used to assess the severity of swallowing disorders, considering excess residue in the pharynx and larynx. The score ranges from a minimum of 4 to a maximum of 11 and is calculated by summing the scores assigned to: Bolus location Amount of residue Ability to control residue/bolus pooling, assessed based on coughing, throat clearing (raclage), and the number of dry voluntary or reflex swallowing attempts (\<2, 2-5, \>5).

Trial sites (1)

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