Detection of residual consciousness using EEG indicators related to rectal perception: protocol for a diagnostic accuracy study.
Yilin Zhao, Yitong Lian, Yinliang Qi...
https://pubmed.ncbi.nlm.nih.gov/42246050/Actively Recruiting
Led by YiLin Zhao · Updated on 2025-10-06
45
Participants Needed
2
Research Sites
N/A
Total Duration
Disorders of Consciousness DoC occur as a result of severe brain injuries from causes like traumatic brain injury, stroke, cardiac arrest, and other neurological or systemic diseases. The increasing number of survivors with DoC presents significant challenges for healthcare and families. Accurate diagnosis and classification of DoC patients are essential for guiding treatment and improving quality of life. Behavioral assessments like the Coma Recovery Scale-Revised CRS-R are commonly used but can be limited in distinguishing subtle differences, especially between Vegetative StateUnresponsive Wakefulness Syndrome and Minimally Conscious State patients. This research evaluates the use of interoception-related indicators, specifically using rectal stimulation combined with electroencephalogram EEG recordings, to better classify DoC patients. Interoception involves brain communication with internal organs and may remain relatively intact in DoC patients. The study uses a device that inflates a rectal balloon rapidly to stimulate internal signals, recording brain responses via EEG across multiple stimulations. This method aims to add valuable information beyond traditional behavioral assessments. Participants will undergo rectal balloon stimulation while EEG monitors brain activity, with 35 stimulations delivered during the session. Researchers will assess the diagnostic value of these interoceptive EEG indicators to help differentiate levels of consciousness. The study spans from December 2024 to December 2025, with ongoing monitoring and data collection. This approach could provide a more cost-effective and convenient complement to imaging techniques and behavioral tests in evaluating DoC patients.
CONDITIONS
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC
Y
YiLin Zhao
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YiLin Zhao
Lead Sponsor
The Second People's Hospital of Hefei
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive rectal stimulation while EEG signals are recorded to assess interoceptive brain responses related to disorders of consciousness.
1 in-person visit with approximately 35 stimulations
Duration - Up to 12 months
Participants are observed for diagnostic value of EEG indicators over time following the stimulation procedure.
Follow-up assessments as scheduled by the study team
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Yilin Zhao, Yitong Lian, Yinliang Qi...
https://pubmed.ncbi.nlm.nih.gov/42246050/YiLin Zhao
Lead Sponsor
The Second People's Hospital of Hefei
Collaborating Sponsor