RecruitingNCT07208942

Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC

Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in Patients With Disorders of Consciousness

Sponsor

YiLin Zhao

Enrollment

45 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Disorders of Consciousness

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether brain activity (EEG) measured in response to gentle internal body sensations — like mild rectal pressure — can help doctors better understand the level of awareness in patients with disorders of consciousness (such as those in a coma or vegetative state). **You may be eligible if...** - You are 18 or older - You have a disorder of consciousness that has lasted at least 28 days (non-acute stage) - You have had no fever or infection in the past 15 days - You have not taken sedatives or gut-motility drugs recently - Your family has provided consent on your behalf **You may NOT be eligible if...** - Your condition stems from a developmental psychiatric or neurological disorder - You have untreated epilepsy or brain swelling - Your vital signs are unstable - You have a history of bowel disease or abdominal surgery (beyond simple appendectomy) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERectal Stimulation

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