Actively Recruiting
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in Patients With Disorders of Consciousness
Led by YiLin Zhao · Updated on 2025-10-06
45
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
YiLin Zhao
Lead Sponsor
T
The Second People's Hospital of Hefei
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 State/Unresponsive 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
Brief Title
Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in DoC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-acute Disorders of Consciousness (DoC) with disease duration of 28 days or more
- Aged 18 years or older
- No symptoms of fever, infection, or similar conditions within 15 days
- No use of sedatives within 15 days
- No use of drugs affecting gastrointestinal motility within 7 days prior to testing
- Family members have provided informed consent
You will not qualify if you...
- Functional impairments caused by developmental psychiatric disorders or neurological diseases
- Untreated epilepsy
- Untreated cerebral edema
- Unstable vital signs
- History of intestinal diseases
- History of abdominal surgery other than simple appendectomy or cholecystectomy
- Organic diseases such as spinal cord injury, traumatic brain injury, or thyroid dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
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
Trial Site Locations
Total: 2 locations
1
The Second People's Hospital of Hefei
Hefei, Anhui, China, 230000
Actively Recruiting
2
Hangzhou Normal University
Hangzhou, Zhejiang, China, 310000
Enrolling by Invitation
Research Team
Y
YiLin Zhao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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