NCT06922162

Tickle Stimulation in Disorders of Consciousness (DoC)

Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Anna Estraneo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorders of Consciousness

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-07-31
• Completion: 2025-10-31
• First posted: 2025-04-10
• Last updated: 2025-04-23

Locations

2 sites across 2 countries: Belgium, Italy

Regulatory

• FDA-regulated device study