Tickle Stimulation in Disorders of Consciousness (DoC)

NCT06922162 | Recruiting FDA Device

• 1 other identifier: TICKLING-DOC
• Study Type: observational
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Tickle stimulation; Behavioural evaluation; Neurophysiological evaluation; Disorders of Consciousness

Outcome Measures

Primary Outcomes (3)

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

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

  Day 1 (single session)

• Hemodynamic Response Changes Measured by fNIRS During Tickling and Neutral Stimulation

  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.

  Day 1 (single session)

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

  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.

  Day 1 (single session)

Secondary Outcomes (2)

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

  Day 1 (baseline)

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

  Day 1 (baseline)

Study Arms (1)

Patients with Disorders of Consciousness (DoC)

All patients with disorders of consciousness who are consecutively admitted to the participating centers of the study will be enrolled with a diagnosis of disorders of consciousness based on the CRS-R scale, with an age ≥18 years and a time since the event ≥ 28 days.

Behavioral: Tickle stimulation; Device: Neurophysiological Monitoring with SedLine

Interventions

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.

Patients with Disorders of Consciousness (DoC)

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.

Also known as: SedLine EEG Monitor, Masimo SedLine

Patients with Disorders of Consciousness (DoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with DoC who are consecutively admitted to the participating centers of the study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Estraneo: lead

Study Sites (2)

Coma Science Group - University of Liege

Liège, Belgium, 4000, Belgium

COMPLETED

Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anna Estraneo, MD

  Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

• Olivia Gosseries, PhD, Professor

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Abagnale, PhD

CONTACT

+393487520258; sabagnale@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Neurologist Senior researcher

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: June 30, 2023
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the first patient recording data until the last patient.

Locations

BE (1); IT (1)