RecruitingNCT06922162

Tickle Stimulation in Disorders of Consciousness (DoC)

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

Sponsor

Anna Estraneo

Enrollment

45 participants

Start Date

Jun 30, 2023

Study Type

OBSERVATIONAL

Conditions

Disorders of Consciousness

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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.

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Interventions

BEHAVIORALTickle 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.

DEVICENeurophysiological 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.