Tickle Stimulation in Disorders of Consciousness (DoC)

NCT ID: NCT06922162

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-10-31

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.

Detailed 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.

Conditions

Disorders of Consciousness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Tickle stimulation

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Other Intervention Names

SedLine EEG Monitor; Masimo SedLine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anna Estraneo

OTHER

Sponsor Role: lead

Responsible Party

Anna Estraneo

MD Neurologist Senior researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anna Estraneo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Don Gnocchi

Olivia Gosseries, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

Coma Science Group - University of Liege

Liège, Belgium, Belgium

Site Status: COMPLETED

Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, Avellino, Italy

Site Status: RECRUITING

Countries

Belgium; Italy

Central Contacts

Simona Abagnale, PhD

Role: CONTACT

sabagnale@dongnocchi.it

+393487520258

Other Identifiers

TICKLING-DOC

Identifier Type: -

Identifier Source: org_study_id