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Search / Trial NCT06888219

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

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Mar 20, 2025

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Tracheostomy Tube Acupuncture

ClinConnect Summary

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 modalit...

Gender

ALL

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.

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Florence, , Italy

Patients applied

0 patients applied

Trial Officials

Bahia Hakiki

Principal Investigator

IRCCS-Fondazione Don Gnocchi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported