Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC

NCT07208942 | Recruiting

• 1 other identifier: 20241009-2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Study on the Significance and Value of Interoception-Related Indicators in the Classification of Patients with Disorders of Consciousness (DoC) via Rectal Stimulation

Conditions

Disorders of Consciousness

Keywords

Interoceptive; EEG; Rectal Stimulation; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

  December 2024 - December 2025

Study Arms (1)

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).

Device: Rectal Stimulation

Interventions

Rectal Stimulation DEVICE

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

Disorders of consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YiLin Zhao: lead
• The Second People's Hospital of Hefei: collaborator

Study Sites (2)

The Second People's Hospital of Hefei

Hefei, Anhui, 230000, China

RECRUITING

Hangzhou Normal University

Hangzhou, Zhejiang, 310000, China

ENROLLING BY INVITATION

MeSH Terms

Conditions

Consciousness Disorders; Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

YiLin Zhao

CONTACT

18850147114; 2567158152@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: October 6, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)