Tactile Stimulation in Disorders of Consciousness (DoC)
ConditionDisorders of Consciousness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnna Estraneo
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
This trial does not accept healthy volunteersQualifiers
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 population
All patients with DoC who are consecutively admitted to the participating centers of the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tactile stimulation
BehavioralPatients will undergo a resting-state EEG and fNIRS recording, followed by the administration of the SECONDs scale. Tactile stimulation will then be performed on eight areas of the body (internal and external forearms, palms and backs of the hands on both sides) using six different stimuli categorized as pleasant, neutral, or unpleasant. Stimuli will be applied manually in randomized blocks. EEG and fNIRS data will be recorded before, during, and after stimulation. Behavioural responses will be evaluated through video analysis by independent raters. The session will last approximately 90 minutes.
Neurophysiological Monitoring with SedLine
DeviceSedLine is a non-invasive neurophysiological monitoring device used to record the brain's electrical activity (EEG) through frontal electrodes. In this study, SedLine is employed to measure resting-state and stimulus-evoked cortical responses in patients with disorders of consciousness (DoC), in combination with functional near-infrared spectroscopy (fNIRS). The EEG signals are used to assess changes in neural activity before, during, and after tactile stimulation with various affective valences (pleasant, neutral, unpleasant). This combined multimodal approach enhances the understanding of sensory processing and cortical reactivity in patients with impaired consciousness.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with Disorders of Consciousness (DoC)2 interventions
Trial outcomes
Primary outcomes
1
SECONDs Scale Total Score Pre- and Post-Tactile Stimulation
Consciousness level will be assessed using the Simplified Evaluation of CONsciousness Disorders (SECONDs) scale at baseline and after each stimulation block (pleasant, neutral, unpleasant). Score changes will be recorded to evaluate short-term effects of stimulation valence.
Time frame
Day 1 (immediately before and after each stimulation block)2
Behavioral Response Scores During Tactile Stimulation (Video Coding)
Video recordings will be rated by two independent observers for presence and intensity of facial expressions, vocalizations, body movements, and emotional indicator. A composite behavioral response score will be computed for each stimulus type.
Time frame
Day 1 (during stimulation phase)3
Hemodynamic Response Changes to Tactile Stimuli Measured by fNIRS
Changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations will be measured using functional near-infrared spectroscopy (fNIRS) over frontal areas. Signal changes will be analyzed by stimulus valence and correlated with behavioural responses.
Time frame
Day 1 (before, during, and after stimulation)4
Cortical Activation Patterns During Tactile Stimulation (EEG - SedLine)
EEG signals will be recorded via SedLine during the full session. Changes in spectral power (e.g., delta, theta, alpha, beta bands) will be analyzed across stimulation blocks to determine cortical reactivity to pleasant, neutral, and unpleasant touch.
Time frame
Day 1 (before, during, and after stimulation)Secondary outcomes
1
Change in Simplified Evaluation of CONsciousness Disorders (SECONDs) Score From Baseline to Post-Stimulation
The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a clinical scale used to quantify the patient's consciousness level. It consists of six behavioural items with a total score ranging from 0 to 8, where higher scores represent better levels of consciousness. The Simplified Evaluation of CONsciousness Disorders (SECONDs) scores will be submitted before and after each stimulation block and will be compared to determine short-term modulation of consciousness level to explore the value of somatosensory processing responses of patients.
Time frame
Day 1 (pre and post each of the 3 stimulation blocks)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Estraneo
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
University of Liege
Collaborator
Source ClinicalTrials.gov
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