Clinical trial NCT06922162: Tickle Stimulation in Disorders of Consciousness (DoC)
Official title: Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disorders of Consciousness
Keywords: Tickle stimulation
Behavioural evaluation
Neurophysiological evaluation
Disorders of Consciousness
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with DoC who are consecutively admitted to the participating centers of the study.

Brief summary: 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.

Detailed description: During the experimental session, patients will undergo the CRS-R and the Nociception Coma Scale-Revised (NCS-R) to ensure that any responses to tickling are not influenced by pain sensations. Subsequently, fNIRS detection optodes will be placed using a non-invasive frontal headband. A 10-minute resting-state recording will be performed. Next, patients will be subjected to tickling: they will be tickled bilaterally in the three most ticklish areas identified in a pilot study with healthy subjects-namely, the soles of the feet, the armpits, and the ribs-plus a control area, the forehead. The stimulation will be manual and will be performed by rubbing the targeted body part while opening and closing fingers in pairs in an arched motion. Additionally, patients will also receive a neutral stimulation (in the same body areas), which consists of simply touching the area without inducing tickling. The order of stimulations will follow a randomized list. Each stimulation will last for 5 seconds, followed by 5 seconds of rest, repeated twice. In total, patients will be stimulated for 10 seconds plus 5 seconds of rest (15 seconds in total) for each body area. There will be a 1-minute pause between each area. Afterward, an additional 10 minute resting-state fNIRS recording will be conducted. During the experimental session, patients will be filmed so that the videos can be analyzed by two different experimenters, who will assess differences between stimulations based on facial expressions, verbalizations/vocalizations, body movements, and changes in emotional state (e.g., crying, smiling, grimacing). At the end of the protocol, the fNIRS optodes will be removed. In total, the experiment will last approximately one hour and fifteen minutes: 30 minutes for CRS-R/NCS-R and 45 minutes for the tickling protocol and fNIRS recording.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale;
* Age ≥18 years;
* Time since the event ≥ 28 days

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Behavioral Response Scores During Tickling and Neutral Stimulation (Video Coding)
timeFrame: Day 1 (single session)
measure: Hemodynamic Response Changes Measured by fNIRS During Tickling and Neutral Stimulation
timeFrame: Day 1 (single session)
measure: Cortical EEG Activation Patterns During Tickling and Neutral Stimulation (SedLine)
timeFrame: Day 1 (single session)
Secondary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R) Total Score Prior to Tickling Stimulation
timeFrame: Day 1 (baseline)
measure: Nociception Coma Scale-Revised (NCS-R) Total Score Prior to Stimulation
timeFrame: Day 1 (baseline)
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Coma Science Group - University of Liege
city: Sant'Angelo dei Lombardi
country: Italy
facility: Fondazione Don Gnocchi
state: Avellino
Study officials:
affiliation: Fondazione Don Gnocchi
name: Anna Estraneo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Olivia Gosseries, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References: