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Rectal balloon test may reveal hidden consciousness

NCT ID NCT07208942

Diagnosis Sponsor: YiLin Zhao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study explores whether measuring brain activity during a brief rectal balloon inflation can help doctors tell the difference between patients who are minimally conscious and those who are unresponsive. Researchers will record EEGs in 45 patients with disorders of consciousness and healthy volunteers. The goal is to develop an objective test for diagnosing levels of awareness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rectal balloon stimulation device
What this could lead to
If successful, this could provide a new, objective way to classify consciousness levels in patients with disorders like unresponsive wakefulness syndrome or minimally conscious state.
What could go wrong
This is a small, early-stage study with only 45 participants. The approach is experimental and may not reliably distinguish between patient groups or translate to broader clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients assessed as Minimally Conscious State plus/minus (MCS+/-) and Unresponsive Wakefulness Syndrome (UWS) using the Coma Recovery Scale-Revised (CRS-R)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disorders of consciousness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hangzhou Normal University

    ENROLLING_BY_INVITATION

    Hangzhou, Zhejiang, 310000, China

  • The Second People's Hospital of Hefei

    RECRUITING

    Hefei, Anhui, 230000, China

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