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RECRUITING
NCT07208942

Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC

Sponsor: YiLin Zhao

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2024-12-01

Completion Date

2025-12

Last Updated

2025-10-06

Healthy Volunteers

Yes

Interventions

DEVICE

Rectal 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

Locations (2)

The Second People's Hospital of Hefei

Hefei, Anhui, China

Hangzhou Normal University

Hangzhou, Zhejiang, China