Tactile Stimulation in Disorders of Consciousness (DoC)

Not yet recruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

July 31, 2025

Study Completion Date

October 31, 2025

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.

All Listed Sponsors
collaborator

University of Liege

OTHER

lead

Anna Estraneo

OTHER

NCT06922123 - Tactile Stimulation in Disorders of Consciousness (DoC) | Biotech Hunter | Biotech Hunter