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NCT Number: NCT06922123

Tactile Stimulation in Disorders of Consciousness (DoC)

The aim of this project is to evaluate the behavioural and neurophysiological responses to pleasant touch in patients with disorders of consciousness (DoC) and to determine whether these responses are related to the level of consciousness. Specifically, the study aims to:

1. explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC; 2. determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness; 3. assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant); 4. examine neurophysiological responses to tactile stimulation using functional near-infrared spectroscopy (fNIRS), and evaluate whether brain activation patterns are associated with behavioural responses; 5. improve diagnostic accuracy in patients with DoC by exploring the value of somatosensory responses in distinguishing unresponsive wakefulness syndrome (UWS) from minimally conscious state (MCS) or conscious patients; 6. explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.

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Key information

About this study

Patients will be enrolled at the participating centers and included in the study only after at least two evaluations using the Coma Recovery Scale-Revised (CRS-R), in order to ensure a stable diagnosis of the level of consciousness.

At the beginning of the protocol, non-invasive fNIRS optodes will be placed on the patient's forehead using a frontal headband, and 15 minutes of resting-state brain activity will be recorded. The Simplified Evaluation of CONsciousness Disorders (SECONDs) will then be administered to assess the patient's level of consciousness, followed by the tactile stimulation protocol.

The tactile stimulation protocol involves 8 areas of the body (anterior and posterior forearm, palm and back of the hand, on both right and left sides) and 6 stimuli grouped into three categories: pleasant objects (makeup brush, plush fabric), neutral objects (sponge, rubber fabric), and unpleasant objects (dishnet, hairbrush). Each stimulus is mounted on a 10 cm wooden stick attached to a cork base. Each stimulation lasts 15 seconds and is manually administered using light circular movements over an area of approximately 5 cm² at a speed of 5 cm/s, following a randomized sequence. A 10-second rest period will be provided between stimulations. Patients will receive three distinct blocks of stimulation: unpleasant stimuli (first block), pleasant stimuli (second block), and neutral stimuli (third block), with the block order randomized across participants. After each block, the SECONDs will be re-administered to detect any changes in the level of consciousness. An additional 15-minute resting-state fNIRS recording will follow the stimulation phase.

All sessions will be video-recorded to allow two independent experimenters to evaluate behavioural responses (e.g., facial expressions, vocalizations, body movements, and emotional reactions such as crying, smiling, or grimacing) and compare the effects of different stimulations. At the end of the session, fNIRS optodes will be removed.

The entire experimental procedure will last approximately 90 minutes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of a disorder of consciousness (DoC), as determined by repeated Coma Recovery Scale-Revised (CRS-R) assessments;
  • Age ≥ 18 years;
  • Time since acute event ≥ 28 days.
  • Written informed consent obtained from the legal representative

Exclusion criteria

  • Presence of large craniectomy that may interfere with fNIRS signal acquisition;
  • Unstable clinical conditions (e.g., respiratory insufficiency, fever, status epilepticus);
  • Fractures, paralysis, lesions, or muscular atrophy that prevent proper tactile stimulation of the specified body areas;
  • Absence of informed consent from the legal representative.

Treatment and study plan

Tactile stimulation

Behavioral

Patients will undergo a resting-state EEG and fNIRS recording, followed by the administration of the SECONDs scale. Tactile stimulation will then be performed on eight areas of the body (internal and external forearms, palms and backs of the hands on both sides) using six different stimuli categorized as pleasant, neutral, or unpleasant. Stimuli will be applied manually in randomized blocks. EEG and fNIRS data will be recorded before, during, and after stimulation. Behavioural responses will be evaluated through video analysis by independent raters. The session will last approximately 90 minutes.

Neurophysiological Monitoring with SedLine

Device

SedLine is a non-invasive neurophysiological monitoring device used to record the brain's electrical activity (EEG) through frontal electrodes. In this study, SedLine is employed to measure resting-state and stimulus-evoked cortical responses in patients with disorders of consciousness (DoC), in combination with functional near-infrared spectroscopy (fNIRS). The EEG signals are used to assess changes in neural activity before, during, and after tactile stimulation with various affective valences (pleasant, neutral, unpleasant). This combined multimodal approach enhances the understanding of sensory processing and cortical reactivity in patients with impaired consciousness.

Other names: SedLine EEG Monitor, Masimo SedLine

Primary outcomes

  1. SECONDs Scale Total Score Pre- and Post-Tactile Stimulation

    Time frame: Day 1 (immediately before and after each stimulation block)

    Consciousness level will be assessed using the Simplified Evaluation of CONsciousness Disorders (SECONDs) scale at baseline and after each stimulation block (pleasant, neutral, unpleasant). Score changes will be recorded to evaluate short-term effects of stimulation valence.

  2. Behavioral Response Scores During Tactile Stimulation (Video Coding)

    Time frame: Day 1 (during stimulation phase)

    Video recordings will be rated by two independent observers for presence and intensity of facial expressions, vocalizations, body movements, and emotional indicator. A composite behavioral response score will be computed for each stimulus type.

  3. Hemodynamic Response Changes to Tactile Stimuli Measured by fNIRS

    Time frame: Day 1 (before, during, and after stimulation)

    Changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations will be measured using functional near-infrared spectroscopy (fNIRS) over frontal areas. Signal changes will be analyzed by stimulus valence and correlated with behavioural responses.

  4. Cortical Activation Patterns During Tactile Stimulation (EEG - SedLine)

    Time frame: Day 1 (before, during, and after stimulation)

    EEG signals will be recorded via SedLine during the full session. Changes in spectral power (e.g., delta, theta, alpha, beta bands) will be analyzed across stimulation blocks to determine cortical reactivity to pleasant, neutral, and unpleasant touch.

Secondary outcomes

  1. Change in Simplified Evaluation of CONsciousness Disorders (SECONDs) Score From Baseline to Post-Stimulation

    Time frame: Day 1 (pre and post each of the 3 stimulation blocks)

    The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a clinical scale used to quantify the patient's consciousness level. It consists of six behavioural items with a total score ranging from 0 to 8, where higher scores represent better levels of consciousness. The Simplified Evaluation of CONsciousness Disorders (SECONDs) scores will be submitted before and after each stimulation block and will be compared to determine short-term modulation of consciousness level to explore the value of somatosensory processing responses of patients.

Study contacts

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

Anna Estraneo, MD Study Principal Investigat

CONTACT

[email protected]

Simona Simona Abagnale, PhD

CONTACT

[email protected]

+39 3487520258

Sponsors and collaborators

Lead sponsor

Anna Estraneo

Other

Collaborators

  • University of Liege

Registry information

Official study title

Behavioural and Neurophysiological Reactions During Tactile Stimulation in Patients Suffering From Disorders of Consciousness (DoC)

Acronym: TACTILE-DOC

Important dates

Study start
2025
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.

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