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Ear needles may help wake brain injury patients

NCT ID NCT07273864

Symptom relief Sponsor: Li Hai Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding ear acupuncture (auricular thumbtack needle therapy) to standard care and nerve stimulation could help people with traumatic brain injury regain consciousness. Sixty patients with a Glasgow Coma Scale score of 4-8 were randomly assigned to receive either standard care plus nerve stimulation alone or the same plus ear acupuncture. The researchers measured awakening rates, coma recovery scores, and family satisfaction over 8 weeks.

What this could mean

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

Active substance
auricular thumbtack needle therapy (ear acupuncture)
What this could lead to
If effective, this could offer a simple, low-cost add-on therapy to help brain-injury patients regain consciousness faster.
What could go wrong
This is a small, single-center trial with only 60 participants. The results may not apply to all brain injury patients, and the effect may be modest or due to chance.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Feb 2022

Finished

Mar 2024

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.

Ages

20 to 86 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Disorder of consciousness following traumatic brain injury * Stable vital signs with no evidence of active bleeding * Glasgow Coma Scale (GCS) score between 4 and 8 (inclusive) * No severe vital organ dysfunction and normal cardiac function * Time from injury to enrollment ≤ 10 days * No prior history of traumatic brain injury, epilepsy, or pregnancy Exclusion Criteria: * Presence of other critical illnesses (e.g., severe cardiovascular, hepatic, or renal disease) * Known allergy to the electrodes or adhesive patches used in electrical stimulation * Lack of cooperation or refusal by the patient's legal guardian/family members

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Consciousness Disorders intracerebral hemorrhage traumatic brain injury

As listed by the trial registrant

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

Cerebral hemorrhage Traumatic brain injury

Contacts and locations

Locations

  • The First Affiliated Hospital of Gannan Medical University

    Jiangxi, Ganzhou, 341000, China

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