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RECRUITING
NCT06922162

Tickle Stimulation in Disorders of Consciousness (DoC)

Sponsor: Anna Estraneo

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2023-06-30

Completion Date

2025-10-31

Last Updated

2025-04-23

Healthy Volunteers

No

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 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.

Locations (2)

Coma Science Group - University of Liege

Liège, Belgium, Belgium

Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, Avellino, Italy