Rectal stimulation with EEG to help diagnose disorders of consciousness
Official title: Diagnosis Value of Interoceptive EEG Indicators by Rectal Stimulation in Patients With Disorders of Consciousness
Run by Hangzhou Normal University · NCT07208942 · Data updated 2026-11-12
This tests whether brief rectal stimulation paired with EEG can reveal brain signals that help diagnose adults who have had a disorder of consciousness for at least 28 days.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Hangzhou Normal University Academic / other |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT07208942 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with a non-acute disorder of consciousness (duration ≥28 days) who are medically stable, not recently on sedatives or GI‑motility drugs, and whose families can give consent.
✕Probably not a fit
Patients with active infection, recent sedative use, known intestinal disease or prior major abdominal surgery, untreated epilepsy, unstable vital signs, or acute DoC (<28 days) are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol records EEG responses to controlled rectal stimulation in adult patients with non-acute disorders of consciousness. Investigators will analyze interoception-related EEG indicators and compare them with the Coma Recovery Scale-Revised behavioral classifications to determine concordance. Eligible patients must be medically stable, off sedatives and drugs affecting gut motility, and free of recent infection or major abdominal disease. The work is conducted at The Second People's Hospital of Hefei and Hangzhou Normal University with in-person EEG and stimulation sessions.
Why it matters
Potential benefit: If successful, the method could provide an objective EEG biomarker to detect covert consciousness and guide diagnosis and rehabilitation planning.
How similar studies have gone: EEG markers from sensory stimulation paradigms have shown promise for detecting covert consciousness, but using rectal interoceptive stimulation is largely novel and has limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with non-acute Disorders of Consciousness (DoC) (disease course ≥ 28 days). * Aged 18 years or older. * No symptoms of fever, infection, or other similar conditions within 15 days. * No use of sedatives within 15 days. * No use of any drugs that may alter gastrointestinal motility within 7 days prior to testing. * Family members of participating patients have provided consent and signed the informed consent form. Exclusion Criteria: * Patients with functional impairments caused by developmental psychiatric disorders or neurological diseases. * Patients with untreated epilepsy. * Untreated cerebral edema. * Patients with unstable vital signs. * A history of intestinal diseases. * A history of abdominal surgery other than simple appendectomy or simple cholecystectomy. * Organic diseases such as spinal cord injury, traumatic brain injury, and thyroid dysfunction.
Where it's running
-
The Second People's Hospital of Hefei
Hefei, Anhui, China Recruiting -
Hangzhou Normal University
Hangzhou, Zhejiang, China Enrolling by invitation
Study contacts
- Study coordinator: YiLin Zhao
- Email: 2567158152@qq.com
- Phone: 18850147114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.