Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC

ConditionDisorders of Consciousness

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorYiLin Zhao

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with functional impairments caused by developmental psychiatric disorders or neurological diseases.

Patients with untreated epilepsy.

Untreated cerebral edema.

Patients with unstable vital signs.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: Disorders of consciousness1 intervention

Trial outcomes

Primary outcomes

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

Time frame

December 2024 - December 2025

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

YiLin Zhao

Lead sponsor

Hangzhou Normal University

Sponsor institution

The Second People's Hospital of Hefei

Collaborator

Source ClinicalTrials.gov

Apply now