Disorders of ConsciousnessNCT07208942
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC
An observational study of Disorders of Consciousness, run by YiLin Zhao at 2 sites in China.
Trial summary
Study on the Significance and Value of Interoception-Related Indicators in the Classification of Patients with Disorders of Consciousness (DoC) via Rectal Stimulation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Rectal Stimulation
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R)
Who may be able to join
- Patients with non-acute Disorders of Consciousness (DoC) (disease course ≥ 28 days).
- Aged 18 years or older.
- No symptoms of fever, infection, or other similar conditions within 15 days.
- No use of sedatives within 15 days.
- No use of any drugs that may alter gastrointestinal motility within 7 days prior to testing.
- Family members of participating patients have provided consent and signed the informed consent form.
Who cannot join
- Patients with functional impairments caused by developmental psychiatric disorders or neurological diseases.
- Patients with untreated epilepsy.
- Untreated cerebral edema.
- Patients with unstable vital signs.
- A history of intestinal diseases.
- A history of abdominal surgery other than simple appendectomy or simple cholecystectomy.
- Organic diseases such as spinal cord injury, traumatic brain injury, and thyroid dysfunction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Enrolling by invitation
Hangzhou Normal University
Hangzhou, Zhejiang, 310000
- Recruiting
The Second People's Hospital of Hefei
Hefei, Anhui, 230000
Yinliang QI, 131099359067, 2567158152@qq.com
Haibo Di, 13588859929, 2567158152@qq.com
About this study
Official title: Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in Patients With Disorders of Consciousness
Study on the Significance and Value of Interoception-Related Indicators in the Classification of Patients with Disorders of Consciousness (DoC) via Rectal Stimulation
Read the detailed description
Disorders of Consciousness (DoC) represent one of the sequelae of severe brain injuries caused by a variety of etiologies, including traumatic brain injury, stroke, and cardiac arrest. They may also result from primary neurological damage or systemic diseases. In recent years, with the advancement and development of surgical techniques and intensive care practices, an increasing number of DoC patients have survived life-threatening severe brain trauma. The large population of DoC patients imposes substantial psychological stress and economic burden on healthcare systems, social welfare services, and patients' families. Accurate identification and classification of DoC patients constitute a crucial prerequisite for clinical treatment and care.
Behavioral assessment of consciousness is currently the most common method for classifying DoC patients and is of great importance for critically ill patients. However, some cases of covert consciousness are difficult to identify, and even professional medical caregivers may encounter assessment errors. Such errors can lead to deviations in the selection of treatment strategies and the evaluation of prognostic efficacy for these patients. Precise diagnosis and classification of DoC are critical for prognostic treatment, as they enable the development of more rational rehabilitation protocols for patients and contribute to improving their quality of life.
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral tool for the diagnosis of DoC. It primarily assesses patients' behavioral responses elicited by external sensory stimuli. The scale comprises six subscales: Auditory, Visual, Motor, Oromotor, Communication, and Arousal. Each subscale has a specific scoring range, with a total possible score of 23. Different total scores allow for the classification of patients into three categories: Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS), Minimally Conscious State (MCS, further divided into MCS+ and MCS-), and Emergent Minimally Conscious State (eMCS). However, the diagnosis and classification of VS/UWS and MCS using this scale are particularly challenging. This is because patients at the boundary between these two categories often exhibit highly similar behavioral responses to external stimuli, with only subtle differences. Additionally, the responses of DoC patients to behavioral assessments may be mere low-level reflexes or lack conscious involvement, making it difficult to achieve precise classification of DoC patients based solely on behavioral assessments.
Interoception refers to the bidirectional communication between the brain and the body's internal organs. Signals from internal organs-such as those related to heartbeat, respiratory movements, and gastrointestinal peristalsis-are transmitted to the cerebral cortex (including the insula and motor cortex) via the autonomic nervous system. Conversely, these cortical regions regulate the activity of target organs through the sympathetic and parasympathetic nervous systems. Interoception is essential for the maintenance of bodily homeostasis. Furthermore, a growing body of evidence indicates that interoception is also involved in higher cognitive functions, such as memory formation, emotional processing, and even the construction of the sense of self. Compared with exteroceptive pathways, the ascending interoceptive pathways in DoC patients tend to remain relatively intact. Therefore, interoception-related indicators, as a complement to exteroceptive behavioral response indicators, hold significant clinical value for the precise assessment of DoC patients.
Research on interoception-related indicators has emerged as a novel field for the differential diagnosis of DoC patients. These indicators serve as a vital supplement to behavioral and imaging assessments. Moreover, their application requires patients to engage in active conscious participation and induce awareness, which means interoception-related indicators can undertake the assessment tasks typically performed by imaging techniques in a more cost-effective and convenient manner. Consequently, they have inevitably become a focus of research in the field of consciousness and consciousness assessment.
- Conditions
- Disorders of Consciousness
- Being tested
- Rectal Stimulation
- Keywords
- Interoceptive, EEG, Rectal Stimulation, Diagnosis
- Medical subject headings
- Consciousness Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal StimulationDevice
The stimulation balloon was lubricated with paraffin oil and inserted until the distal end of the balloon was 10 cm from the anal verge, so as to eliminate the influence of different stimulation sites on the subjects.
At the start of stimulation, the dilatable balloon was rapidly inflated to 60/80 mL, with a stimulation duration of 150 milliseconds. Concurrently with stimulation, the onset time of stimulation was marked on the electroencephalogram (EEG), and the time window for cortical potentials evoked by rapid rectal balloon distension stimulation was recorded. During the experiment, 35 stimulations were administered to the subjects; however, the first and last stimulations were excluded due to setup issues with the precision inflation-deflation control device for the intestinal balloon. Each stimulation was delivered as a 150-millisecond inflation pulse, providing 35 identical rectal stimulations. The inter-stimulus interval was randomly set to 12 ± 4 seconds, and EEG signals were
| Study group | Role | What they receive |
|---|---|---|
| Disorders of consciousness | Patients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R). Receives: Device: Rectal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation inDoC
This study aims to develop and validate an objective neurophysiological biomarker for classifying consciousness levels in patients with Disorders of Consciousness (DoC), such as the Unresponsive Wakefulness Syndrome (UWS) and the Minimally Conscious State (MCS). The primary objective is to determine whether cortical responses to a rectal balloon distension stimulus, which engages preserved interoceptive neural pathways, can effectively differentiate between these patient groups and healthy controls. In this prospective, case-control study, participants (DoC patients and healthy controls) will undergo electroencephalography (EEG) recording during a standardized rectal stimulation paradigm. The primary outcome measures will include the amplitude of event-related potential (ERP) components (N1, P2, P3) at central (Cz) and frontal (Fz) electrodes, and the spectral power in the theta band (3-5 Hz) derived from Event-Related Spectral Perturbation (ERSP) analysis. The findings are expected t
Measured: December 2024 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiLin Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Hefei
- Responsible party
- Sponsor-investigator, YiLin Zhao, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208942
- Sponsor's protocol ID
- 20241009-2
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao Y, Lian Y, Qi Y, Laureys S, Di H, Zhao W. Detection of residual consciousness using EEG indicators related to rectal perception: protocol for a diagnostic accuracy study. Front Neurol. 2026 May 20;17:1802303. doi: 10.3389/fneur.2026.1802303. eCollection 2026.
PubMed 42246050
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT07208942
- Acronym / sponsor ID
- 20241009-2
- Conditions
- Disorders of Consciousness
- Keywords
- Interoceptive, EEG, Rectal Stimulation, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- YiLin ZhaoUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Hefei
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Oct 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.
Study on the Significance and Value of Interoception-Related Indicators in the Classification of Patients with Disorders of Consciousness (DoC) via Rectal Stimulation
Detailed description
Disorders of Consciousness (DoC) represent one of the sequelae of severe brain injuries caused by a variety of etiologies, including traumatic brain injury, stroke, and cardiac arrest. They may also result from primary neurological damage or systemic diseases. In recent years, with the advancement and development of surgical techniques and intensive care practices, an increasing number of DoC patients have survived life-threatening severe brain trauma. The large population of DoC patients imposes substantial psychological stress and economic burden on healthcare systems, social welfare services, and patients' families. Accurate identification and classification of DoC patients constitute a crucial prerequisite for clinical treatment and care.
Behavioral assessment of consciousness is currently the most common method for classifying DoC patients and is of great importance for critically ill patients. However, some cases of covert consciousness are difficult to identify, and even professional medical caregivers may encounter assessment errors. Such errors can lead to deviations in the selection of treatment strategies and the evaluation of prognostic efficacy for these patients. Precise diagnosis and classification of DoC are critical for prognostic treatment, as they enable the development of more rational rehabilitation protocols for patients and contribute to improving their quality of life.
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral tool for the diagnosis of DoC. It primarily assesses patients' behavioral responses elicited by external sensory stimuli. The scale comprises six subscales: Auditory, Visual, Motor, Oromotor, Communication, and Arousal. Each subscale has a specific scoring range, with a total possible score of 23. Different total scores allow for the classification of patients into three categories: Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS), Minimally Conscious State (MCS, further divided into MCS+ and MCS-), and Emergent Minimally Conscious State (eMCS). However, the diagnosis and classification of VS/UWS and MCS using this scale are particularly challenging. This is because patients at the boundary between these two categories often exhibit highly similar behavioral responses to external stimuli, with only subtle differences. Additionally, the responses of DoC patients to behavioral assessments may be mere low-level reflexes or lack conscious involvement, making it difficult to achieve precise classification of DoC patients based solely on behavioral assessments.
Interoception refers to the bidirectional communication between the brain and the body's internal organs. Signals from internal organs-such as those related to heartbeat, respiratory movements, and gastrointestinal peristalsis-are transmitted to the cerebral cortex (including the insula and motor cortex) via the autonomic nervous system. Conversely, these cortical regions regulate the activity of target organs through the sympathetic and parasympathetic nervous systems. Interoception is essential for the maintenance of bodily homeostasis. Furthermore, a growing body of evidence indicates that interoception is also involved in higher cognitive functions, such as memory formation, emotional processing, and even the construction of the sense of self. Compared with exteroceptive pathways, the ascending interoceptive pathways in DoC patients tend to remain relatively intact. Therefore, interoception-related indicators, as a complement to exteroceptive behavioral response indicators, hold significant clinical value for the precise assessment of DoC patients.
Research on interoception-related indicators has emerged as a novel field for the differential diagnosis of DoC patients. These indicators serve as a vital supplement to behavioral and imaging assessments. Moreover, their application requires patients to engage in active conscious participation and induce awareness, which means interoception-related indicators can undertake the assessment tasks typically performed by imaging techniques in a more cost-effective and convenient manner. Consequently, they have inevitably become a focus of research in the field of consciousness and consciousness assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disorders of consciousness | – | Device: Rectal StimulationPatients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R)
Key inclusion criteria (6 listed)
- Patients with non-acute Disorders of Consciousness (DoC) (disease course ≥ 28 days).
- Aged 18 years or older.
- No symptoms of fever, infection, or other similar conditions within 15 days.
- No use of sedatives within 15 days.
- No use of any drugs that may alter gastrointestinal motility within 7 days prior to testing.
Key exclusion criteria (7 listed)
- Patients with functional impairments caused by developmental psychiatric disorders or neurological diseases.
- Patients with untreated epilepsy.
- Untreated cerebral edema.
- Patients with unstable vital signs.
- A history of intestinal diseases.
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 |
|---|---|---|
| Rectal StimulationThe stimulation balloon was lubricated with paraffin oil and inserted until the distal end of the balloon was 10 cm from the anal verge, so as to eliminate the influence of different stimulation sites on the subjects. At the start of stimulation, the dilatable balloon was rapidly inflated to 60/80 mL, with a stimulation duration of 150 milliseconds. Concurrently with stimulation, the onset time of stimulation was marked on the electroencephalogram (EEG), and the time window for cortical potentials evoked by rapid rectal balloon distension stimulation was recorded. During the experiment, 35 stimulations were administered to the subjects; however, the first and last stimulations were excluded due to setup issues with the precision inflation-deflation control device for the intestinal balloon. Each stimulation was delivered as a 150-millisecond inflation pulse, providing 35 identical rectal stimulations. The inter-stimulus interval was randomly set to 12 ± 4 seconds, and EEG signals were | Device | Disorders of consciousness |
Primary outcome
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation inDoC
Time frame: December 2024 - December 2025
This study aims to develop and validate an objective neurophysiological biomarker for classifying consciousness levels in patients with Disorders of Consciousness (DoC), such as the Unresponsive Wakefulness Syndrome (UWS) and the Minimally Conscious State (MCS). The primary objective is to determine whether cortical responses to a rectal balloon distension stimulus, which engages preserved interoceptive neural pathways, can effectively differentiate between these patient groups and healthy controls. In this prospective, case-control study, participants (DoC patients and healthy controls) will undergo electroencephalography (EEG) recording during a standardized rectal stimulation paradigm. The primary outcome measures will include the amplitude of event-related potential (ERP) components (N1, P2, P3) at central (Cz) and frontal (Fz) electrodes, and the spectral power in the theta band (3-5 Hz) derived from Event-Related Spectral Perturbation (ERSP) analysis. The findings are expected t
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 42246050Zhao Y, Lian Y, Qi Y, Laureys S, Di H, Zhao W. Detection of residual consciousness using EEG indicators related to rectal perception: protocol for a diagnostic accuracy study. Front Neurol. 2026 May 20;17:1802303. doi: 10.3389/fneur.2026.1802303. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
2 sites 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 YiLin Zhao at 2 sites in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YiLin Zhao (18850147114, 2567158152@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation inDoC (time frame: December 2024 - December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208942, which also lists 1 linked publication.
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 6 Oct 2025.