Tickle Stimulation in Disorders of Consciousness (DoC)

Last updated: April 17, 2025
Sponsor: Anna Estraneo
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Neurophysiological Monitoring with SedLine

Tickle stimulation

Clinical Study ID

NCT06922162
TICKLING-DOC
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale;

  • Age ≥18 years;

  • Time since the event ≥ 28 days

Exclusion

Exclusion Criteria:

  • Large craniectomy that may interfere with fNIRS recording; Unstable clinicalconditions (e.g., respiratory failure, fever, status epilepticus, etc.);

  • Fractures, paralysis, injuries, or muscular dystrophy that prevent properstimulation of the aforementioned body parts;

  • Lack of informed consent from the legal representative.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Neurophysiological Monitoring with SedLine
Phase:
Study Start date:
June 30, 2023
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Coma Science Group - University of Liege

    Liege, 4000
    Belgium

    Completed

  • Fondazione Don Gnocchi

    Sant'Angelo dei Lombardi, Avellino 83054
    Italy

    Active - Recruiting

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