Disorders of ConsciousnessTACTILE-DOCNCT06922123
Tactile Stimulation in Disorders of Consciousness (DoC)
An observational study of Disorders of Consciousness, run by Anna Estraneo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Tactile stimulation and Neurophysiological Monitoring with SedLine
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2025to 16 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with DoC who are consecutively admitted to the participating centers of the study
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi
Sant'Angelo dei Lombardi, Avellino, 83054
About this study
Official title: Behavioural and Neurophysiological Reactions During Tactile Stimulation in Patients Suffering From 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:
- explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC;
- determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness;
- assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant);
- examine neurophysiological responses to tactile stimulation using functional near-infrared spectroscopy (fNIRS), and evaluate whether brain activation patterns are associated with behavioural responses;
- 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;
- explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.
Read the detailed description
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.
- Conditions
- Disorders of Consciousness
- Being tested
- Tactile stimulation, Neurophysiological Monitoring with SedLine
- Keywords
- Tactile stimulation, Disorders of Consciousness, Behavioural evaluation, Neurophysiological evaluation, Pleasant touch stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulationBehavioural
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 SedLineDevice
Also called SedLine EEG Monitor, Masimo 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tactile stimulation; Device: Neurophysiological Monitoring with SedLine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (before, during, and after stimulation)
Secondary outcomes (1)
Change in Simplified Evaluation of CONsciousness Disorders (SECONDs) Score From Baseline to Post-Stimulation
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.
Measured: Day 1 (pre and post each of the 3 stimulation blocks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start19 Jun 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Estraneo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Sponsor-investigator, Anna Estraneo, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Anna Estraneo, MD, Principal investigator, Fondazione Don GnocchiOlivia Gosseries, PhD, Professor, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922123
- Sponsor's protocol ID
- TACTILE-DOC
- Acronym
- TACTILE-DOC
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD collected throughout the trial (SECONDs, video recordings outcomes, fNIRS, EEG data).
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Neurophysiological Reactions During Tactile Stimulation in Patients Suffering From Disorders of Consciousness (DoC)
- ClinicalTrials.gov ID
- NCT06922123
- Acronym / sponsor ID
- TACTILE-DOC / TACTILE-DOC
- Conditions
- Disorders of Consciousness
- Keywords
- Tactile stimulation, Disorders of Consciousness, Behavioural evaluation, Neurophysiological evaluation, Pleasant touch stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Anna EstraneoUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC;
- determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness;
- assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant);
- examine neurophysiological responses to tactile stimulation using functional near-infrared spectroscopy (fNIRS), and evaluate whether brain activation patterns are associated with behavioural responses;
- 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;
- explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Disorders of Consciousness (DoC) | – | Behavioral: Tactile stimulation, Device: Neurophysiological Monitoring with SedLineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with DoC who are consecutively admitted to the participating centers of the study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile stimulationPatients 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. | Behavioural | Patients with Disorders of Consciousness (DoC) |
| Neurophysiological Monitoring with SedLineAlso: SedLine EEG Monitor, Masimo SedLineSedLine 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. | Device | Patients with Disorders of Consciousness (DoC) |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. IPD collected throughout the trial (SECONDs, video recordings outcomes, fNIRS, EEG data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Estraneo, MD principal investigator
Fondazione Don Gnocchi
Olivia Gosseries, PhD, Professor principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness, run by Anna Estraneo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SECONDs Scale Total Score Pre- and Post-Tactile Stimulation (time frame: Day 1 (immediately before and after each stimulation block)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.