Tickle Stimulation in Disorders of Consciousness (DoC)
ConditionDisorders of Consciousness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnna Estraneo
About this trial
The aim of this project is to investigate whether tickling stimulations can have a short-term effect on the responsiveness of patients with Disorders of Consciousness due to Severe Acquired Brain Injury and to compare this effect with that of neutral tactile stimulations that do not induce tickling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale;
Age ≥18 years;
Time since the event ≥ 28 days
Disqualifiers
Large craniectomy that may interfere with fNIRS recording; Unstable clinical conditions (e.g., respiratory failure, fever, status epilepticus, etc.);
Fractures, paralysis, injuries, or muscular dystrophy that prevent proper stimulation of the aforementioned body parts;
Lack 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
Tickle stimulation
BehavioralPatients will be subjected to tickling: they will be tickled bilaterally in three areas, the soles of the feet, the armpits, and the ribs-plus a control area, the forehead. The stimulation will be manual and performed by rubbing the targeted body part while opening and closing the fingers in pairs in an arched motion. Additionally, patients will also undergo a neutral stimulation (in the same body areas), which consists of simply touching the area without inducing tickling.
Neurophysiological Monitoring with SedLine
DeviceSedLine is a portable, non-invasive EEG monitoring device used to record electrical brain activity through frontal electrodes. In the TICKLING-DOC study, SedLine is used to assess cortical responses in patients with disorders of consciousness (DoC) during manual tactile stimulation, specifically tickling, and neutral touch. The EEG data are recorded before, during, and after stimulation to detect neural reactivity and possible correlations with behavioral responses. The goal is to investigate whether tickle-evoked EEG activity reflects residual consciousness and contributes to diagnostic and rehabilitative strategies. SedLine allows continuous monitoring in a bedside setting, offering safe, real-time assessment of brain function.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Patients with Disorders of Consciousness (DoC)2 interventions
Trial outcomes
Primary outcomes
1
Behavioral Response Scores During Tickling and Neutral Stimulation (Video Coding)
Behavioral responses will be evaluated from video recordings by two blinded raters, based on predefined observational categories (e.g., facial expressions, vocalizations, etc).
Time frame
Day 1 (single session)2
Hemodynamic Response Changes Measured by fNIRS During Tickling and Neutral Stimulation
Oxygenated and deoxygenated hemoglobin changes (HbO/HbR) will be recorded using functional near-infrared spectroscopy (fNIRS) in response to tactile stimulation. Signal changes in prefrontal regions will be analyzed and compared across stimulation types.
Time frame
Day 1 (single session)3
Cortical EEG Activation Patterns During Tickling and Neutral Stimulation (SedLine)
EEG data will be acquired with SedLine during stimulation sessions. Spectral power in defined frequency bands (e.g., alpha, beta) will be analyzed and compared between conditions.
Time frame
Day 1 (single session)Secondary outcomes
1
Coma Recovery Scale-Revised (CRS-R) Total Score Prior to Tickling Stimulation
Coma Recovery Scale-Revised (CRS-R) total score assessed before the stimulation protocol to determine baseline level of consciousness.The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to determine the level of consciousness in patients with disorders of consciousness. Scores range from 0 to 23, with higher scores indicating better consciousness and functional responsiveness.
Time frame
Day 1 (baseline)2
Nociception Coma Scale-Revised (NCS-R) Total Score Prior to Stimulation
NCS-R will be administered before tactile stimulations to assess nociceptive reactivity. The Nociception Coma Scale-Revised (NCS-R) is a standardised behavioural tool used to assess nociceptive responses in patients with disorders of consciousness. It includes three subscales (motor, verbal, and facial responses). Scores range from 0 to 9, with higher scores indicating greater responsiveness to nociceptive stimuli.
Time frame
Day 1 (baseline)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
Source ClinicalTrials.gov