Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07208942

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

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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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