About this trial
The aim of this project is to evaluate the behavioural and neurophysiological responses to pleasant touch in patients with disorders of consciousness (DoC) and to determine whether these responses are related to the level of consciousness. Specifically, the study aims to:
1. explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC; 2. determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness; 3. assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant); 4. examine neurophysiological responses to tactile stimulation using functional near-infrared spectroscopy (fNIRS), and evaluate whether brain activation patterns are associated with behavioural responses; 5. improve diagnostic accuracy in patients with DoC by exploring the value of somatosensory responses in distinguishing unresponsive wakefulness syndrome (UWS) from minimally conscious state (MCS) or conscious patients; 6. explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.
Eligibility criteria
Qualifiers
Clinical diagnosis of a disorder of consciousness (DoC), as determined by repeated Coma Recovery Scale-Revised (CRS-R) assessments;
Age ≥ 18 years;
Time since acute event ≥ 28 days.
Written informed consent obtained from the legal representative
Disqualifiers
Presence of large craniectomy that may interfere with fNIRS signal acquisition;
Unstable clinical conditions (e.g., respiratory insufficiency, fever, status epilepticus);
Fractures, paralysis, lesions, or muscular atrophy that prevent proper tactile stimulation of the specified body areas;
Absence of informed consent from the legal representative.
Trial design
Treatments tested in this trial
- Tactile stimulation
- Neurophysiological Monitoring with SedLine
Treatment groups
Locations
Sponsors and collaborators
Anna Estraneo
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
University of Liege
Collaborator