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

NCT06888219 | Enrolling By Invitation DMC

• 1 other identifier: REDACT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injury; Cognitive Impairment; Deglutition Disorder

Keywords

tracheostomy tube; acupuncture

Outcome Measures

Primary Outcomes (2)

• Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale

  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)

  From enrollment to the end of treatment at 4 weeks and at 3 months

• Significant difference measured by Pooling Score, based on endoscopic landmarks and bedside parameters with relative values

  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).

  From enrollment to the end of treatment at 4 weeks and at 3 months

Study Arms (2)

Acupuncture and Auriculotherapy

EXPERIMENTAL

Patients assigned to the intervention arm will receive conventional speech therapy rehabilitation (as in the control group) along with 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes. The treatment will follow a protocol developed in collaboration with experienced acupuncture physicians and will involve the placement of approximately 10 somatic and auricular needles.

Other: Acupuncture and Auricolotherapy; Other: Conventional logopedic rehabilitation

Conventional speech therapy rehabilitation

ACTIVE COMPARATOR

Patients assigned to the control arm will undergo conventional speech therapy rehabilitation, which involves one hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning.

Other: Conventional logopedic rehabilitation

Interventions

Acupuncture and Auricolotherapy OTHER

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

Acupuncture and Auriculotherapy

Conventional logopedic rehabilitation OTHER

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.

Acupuncture and Auriculotherapy; Conventional speech therapy rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of severe Acquired Brain Injury with vascular etiology (ischemic or hemorrhagic), confirmed by Computerized Tomography or Magnetic Resonance Imaging.
• Time between acute event and enrollment: 1 to 3 months. Age \>18 years. Presence of a tracheal cannula upon admission to the Intensive Rehabilitation Unit.
• Level of Cognitive Functioning (LCF) \< or = 4. Informed consent signed by the patient's legal representative.

You may not qualify if:

• Instability of general clinical conditions, including mechanical ventilation, sedation, sepsis or sub-emergent epileptic seizures.
• Patients in Unresponsive Wakefulness Syndrome (UWS), according to the Coma Recovery Scale-Revised (CRS-R).
• Known agoraphobia.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS-Fondazione Don Gnocchi

Florence, Italy

Location

Related Publications (4)

• Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.

  PMID: 27006423 BACKGROUND

• Garuti G, Reverberi C, Briganti A, Massobrio M, Lombardi F, Lusuardi M. Swallowing disorders in tracheostomised patients: a multidisciplinary/multiprofessional approach in decannulation protocols. Multidiscip Respir Med. 2014 Jun 20;9(1):36. doi: 10.1186/2049-6958-9-36. eCollection 2014.

  PMID: 25006457 BACKGROUND

• Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.

  PMID: 32428445 BACKGROUND

• Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.

  PMID: 18646575 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction; Deglutition Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Bahia Hakiki

  IRCCS-Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 21, 2025
• Study Start: November 25, 2024
• Primary Completion: November 25, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 21, 2025

Record last verified: 2024-10

Locations

IT (1)