Clinical Trial

Tactile Stimulation in Disorders of Consciousness (DoC)

Study acronym: TACTILE-DOC
Not Yet Recruiting
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Record status
This record was last updated April 23, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-03.
Trial Details
NCT Number NCT06922123
Lead Sponsor Anna Estraneo
Collaborators: University of Liege
Conditions Disorders of Consciousness
Enrollment 30 participants
Start Date 2025-04
Primary Completion 2025-07 (estimated)
Study Completion 2025-10 (estimated)
Updated on ClinicalTrials.gov 2025-04-23