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Tactile Stimulation in Disorders of Consciousness (DoC)

NCT06922123 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Disorders of Consciousness

Interventions

BEHAVIORAL

Tactile stimulation

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.

DEVICE

Neurophysiological Monitoring with SedLine

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.

Sponsors & Collaborators

  • University of Liege

    collaborator OTHER

  • Anna Estraneo

    lead OTHER

Principal Investigators

  • Anna Estraneo, MD · Fondazione Don Gnocchi

  • Olivia Gosseries, PhD, Professor · University of Liege

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-07-31
Completion
2025-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922123 on ClinicalTrials.gov