Status:
ENROLLING_BY_INVITATION
Somatic and Ear Acupuncture for Dysphagia Rehabilitation and Decannulation After Severe Acquired Brain Injuries
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Brain Injury
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
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 rehabilita...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06888219
Start Date
November 25 2024
End Date
November 30 2026
Last Update
March 21 2025
Active Locations (1)
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1
IRCCS-Fondazione Don Gnocchi
Florence, Italy