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

NCT ID: NCT06888219

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2026-11-30

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.

Detailed Description

On admission to the Intensive Rehabilitation Unit (IRU), patients with severe Acquired Brain Injury (sABI) often present with severe dysphagia (incidence up to 93%) and require a tracheal cannula (50-70%). During this intensive rehabilitation phase, the restoration of oral feeding and decannulation are two crucial and closely linked objectives. Studies have shown that the inability to manage saliva and dysphagia represents the main obstacle to decannulation, even in the long term.

Due to the extreme heterogeneity of patients with sABI and the lack of guidelines and consensus on the modalities and timing of dysphagia rehabilitation, swallowing rehabilitation still lacks standardization. Furthermore, most dysphagia rehabilitation techniques (both compensatory and restorative) require a certain degree of active patient collaboration, making them difficult to apply in sub-acute sABI patients.

In this context, acupuncture, which is already recommended by various international guidelines for conditions such as spasticity and pain, could be a valid therapeutic option. In fact, this technique has shown potential in reducing sialorrhea and muscular contractures in the oro-facial area, even in non-cooperative patients, such as those with a Disorder of Consciousness (DoC) or cognitive impairment.

This study aims to verify the effectiveness of Acupuncture and Auriculotherapy in the rehabilitation of dysphagia and tracheal cannula weaning in non-cooperative patients with sABI outcomes. The goal is to support the use of a safe, low-cost, bedside technique with no side effects, potentially applicable in all settings and during all rehabilitation phases.

The study will enroll 24 patients admitted to the IRU of the IRCCS-Fondazione Don Gnocchi of Florence for sABI of vascular etiology.

The baseline assessment (T0) at the time of study inclusion will involve the administration of clinical-instrumental scales to measure dysphagia severity:

• Mann Assessment of Swallowing Ability (MASA), assessed by the speech therapist
• Pooling Score, assessed by the phoniatrist using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) A computerized randomization will assign patients to either the Intervention Group or the Control Group.

In both groups, conventional speech therapy rehabilitation will involve 1 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.

The Intervention Group will also undergo 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes.

A follow-up clinical-instrumental assessment is scheduled:

At the end of 4 weeks of treatment (T1) At 3 months after T0 (T2)

Conditions

Brain Injury; Cognitive Impairment; Deglutition Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture and Auriculotherapy

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.

Group Type: EXPERIMENTAL

Acupuncture and Auricolotherapy

Intervention Type: 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

Conventional logopedic rehabilitation

Intervention Type: 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.

Conventional speech therapy rehabilitation

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.

Group Type: ACTIVE_COMPARATOR

Conventional logopedic rehabilitation

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bahia Hakiki

Role: PRINCIPAL_INVESTIGATOR

IRCCS-Fondazione Don Gnocchi

Locations

IRCCS-Fondazione Don Gnocchi

Florence, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 27006423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25006457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32428445 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 18646575 (View on PubMed)

Other Identifiers

REDACT

Identifier Type: -

Identifier Source: org_study_id