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Tickle Stimulation in Disorders of Consciousness (DoC)

NCT06922162 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

  • Disorders of Consciousness

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.

Sponsors & Collaborators

  • Anna Estraneo

    lead OTHER

Principal Investigators

  • Anna Estraneo, MD · Fondazione Don Gnocchi

  • Olivia Gosseries, PhD, Professor · University of Liege

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2025-07-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • Belgium
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922162 on ClinicalTrials.gov