Tactile Stimulation in Disorders of Consciousness (DoC)

NCT06922123 | Not Yet Recruiting FDA Device

• 1 other identifier: TACTILE-DOC
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC;
2. 2.determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness;
3. 3.assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant);
4. 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. 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. 6.explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.

Conditions

Disorders of Consciousness

Keywords

Tactile stimulation; Disorders of Consciousness; Behavioural evaluation; Neurophysiological evaluation; Pleasant touch stimulation

Outcome Measures

Primary Outcomes (4)

• SECONDs Scale Total Score Pre- and Post-Tactile Stimulation

  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.

  Day 1 (immediately before and after each stimulation block)

• Behavioral Response Scores During Tactile Stimulation (Video Coding)

  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.

  Day 1 (during stimulation phase)

• Hemodynamic Response Changes to Tactile Stimuli Measured by fNIRS

  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.

  Day 1 (before, during, and after stimulation)

• Cortical Activation Patterns During Tactile Stimulation (EEG - SedLine)

  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.

  Day 1 (before, during, and after stimulation)

Secondary Outcomes (1)

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

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

Study Arms (1)

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.

Behavioral: Tactile stimulation; Device: Neurophysiological Monitoring with SedLine

Interventions

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.

Patients with Disorders of Consciousness (DoC)

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.

Also known as: SedLine EEG Monitor, Masimo SedLine

Patients with Disorders of Consciousness (DoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with DoC who are consecutively admitted to the participating centers of the study

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Estraneo: lead
• University of Liege: collaborator

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anna Estraneo, MD

  Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

• Olivia Gosseries, PhD, Professor

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Simona Abagnale, PhD

CONTACT

+39 3487520258; sabagnale@dongnocchi.it

Anna Estraneo, MD Study Principal Investigat

CONTACT

aestraneo@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Neurologist Senior researcher

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the first patient recording data until the last patient.