Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06922162

Tickle Stimulation in Disorders of Consciousness (DoC)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coma Science Group - University of Liege, Liège, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Tickle stimulation

Behavioral

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.

Neurophysiological Monitoring with SedLine

Device

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.

Other names: SedLine EEG Monitor, Masimo SedLine

Primary outcomes

  1. Behavioral Response Scores During Tickling and Neutral Stimulation (Video Coding)

    Time frame: Day 1 (single session)

    Behavioral responses will be evaluated from video recordings by two blinded raters, based on predefined observational categories (e.g., facial expressions, vocalizations, etc).

  2. Hemodynamic Response Changes Measured by fNIRS During Tickling and Neutral Stimulation

    Time frame: Day 1 (single session)

    Oxygenated and deoxygenated hemoglobin changes (HbO/HbR) will be recorded using functional near-infrared spectroscopy (fNIRS) in response to tactile stimulation. Signal changes in prefrontal regions will be analyzed and compared across stimulation types.

  3. Cortical EEG Activation Patterns During Tickling and Neutral Stimulation (SedLine)

    Time frame: Day 1 (single session)

    EEG data will be acquired with SedLine during stimulation sessions. Spectral power in defined frequency bands (e.g., alpha, beta) will be analyzed and compared between conditions.

Secondary outcomes

  1. Coma Recovery Scale-Revised (CRS-R) Total Score Prior to Tickling Stimulation

    Time frame: Day 1 (baseline)

    Coma Recovery Scale-Revised (CRS-R) total score assessed before the stimulation protocol to determine baseline level of consciousness.The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to determine the level of consciousness in patients with disorders of consciousness.

    Scores range from 0 to 23, with higher scores indicating better consciousness and functional responsiveness.

  2. Nociception Coma Scale-Revised (NCS-R) Total Score Prior to Stimulation

    Time frame: Day 1 (baseline)

    NCS-R will be administered before tactile stimulations to assess nociceptive reactivity. The Nociception Coma Scale-Revised (NCS-R) is a standardised behavioural tool used to assess nociceptive responses in patients with disorders of consciousness. It includes three subscales (motor, verbal, and facial responses). Scores range from 0 to 9, with higher scores indicating greater responsiveness to nociceptive stimuli.

Study contacts

Contact information is provided by the study sponsor or research team.

Simona Abagnale, PhD

CONTACT

[email protected]

+393487520258

Sponsors and collaborators

Lead sponsor

Anna Estraneo

Other

Registry information

Official study title

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

Acronym: TICKLING-DOC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.