Tickle Stimulation in Disorders of Consciousness (DoC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tickle stimulation, Neurophysiological Monitoring with SedLine.
- Who it may be relevant to
- Registry conditions: Disorders of Consciousness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness
Overview
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.
Interventions
- Behavioral Tickle stimulation
Patients 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. - Device Neurophysiological Monitoring with SedLine
SedLine 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 wh
Primary outcome measures
- Behavioral Response Scores During Tickling and Neutral Stimulation (Video Coding) [Time frame: Day 1 (single session)]
- Hemodynamic Response Changes Measured by fNIRS During Tickling and Neutral Stimulation [Time frame: Day 1 (single session)]
- Cortical EEG Activation Patterns During Tickling and Neutral Stimulation (SedLine) [Time frame: Day 1 (single session)]
Secondary outcome measures (2)
- Coma Recovery Scale-Revised (CRS-R) Total Score Prior to Tickling Stimulation [Time frame: Day 1 (baseline)]
- Nociception Coma Scale-Revised (NCS-R) Total Score Prior to Stimulation [Time frame: Day 1 (baseline)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Coma Science Group - University of Liege — Liège
Italy · 1 center
- Fondazione Don Gnocchi — Sant'Angelo dei Lombardi
Identifiers
NCT: NCT06922162 · TICKLING-DOC