Exploring the effects of surface electrostimulation to improve swallow function in dysphagic patients
- Conditions
- R13.9
- Registration Number
- DRKS00031268
- Lead Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
• Age = 18 = 75 years
• Patients suffering from dysphagia following a minimum of 24h intubation, showing a PAS grade = 3 and/or Yale-Scale score =3 (Valleculae and/or S.Piriformis)
• Patients anatomically, mentally, and psychologically compatible with the criteria for participation in this clinical investigation
• Patients routinely hospitalized for the entire duration of stimulation (i.e., two weeks)
• Highly motivated patients with realistic expectations regarding their participation in this clinical investigation
• Signed and dated informed consent before the start of any clinical investigationspecific procedure for all the recruited subjects (with special rule for patients prevented from writing)
• Lack of compliance with any inclusion criteria
• Pregnant or breast-feeding women
• Diagnosed neurologic or non-neurologic diseases that would affect the dysphagia
symptoms caused by intubation, e.g., apoplex, oropharyngeal dysphagia or diagnosed
oropharyngeal injuries or other impairments
• Current obtunded levels of alertness
• Significant agitation
• Infections, inflammatory processes, or any other conditions or injuries that interest the
external neck region and the throat
• Other clinical conditions that could affect the results of this clinical investigation, e.g.,
respiration issues (decompensated asthma, decompensated COPD) or severe generalized
muscle disease
• Skin defects or wounds in the stimulation area
• Current use of active implants
• Current use of metal implants in the neck region
• Endotracheally intubated patients
• Known allergies or intolerance to the material used for this clinical investigation
• Parallel participation in a device/drug clinical investigation in the period of data collection,
which could confound the results of the clinical investigation 2021CIP005.
• Anything that, in the opinion of the Principal Investigator, would place the subject at
increased risk or preclude the subject's full compliance with the general requirements
of this clinical investigation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method