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Brain scans reveal dopamine disruption in coma patients

NCT ID NCT06930261

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study uses a special PET scan to look at dopamine pathways in the brains of people who are in a coma after a severe head injury. Researchers will compare three groups: coma patients, patients who have recovered from coma, and healthy volunteers. The goal is to understand how dopamine disruptions relate to consciousness and recovery, which could one day lead to better treatments.

What this could mean

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

Active substance
LBT-999 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this study could reveal how dopamine disruptions affect consciousness after traumatic coma, potentially guiding future treatments to aid recovery.
What could go wrong
This is a small, early-phase imaging study (55 participants) that does not test a treatment. It may not lead to direct patient benefits, and results may not apply to all coma patients.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 55 people

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

Started

Jan 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 65 years

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: For All Participants: * Aged 18-65 years. * Affiliated with or beneficiary of a social security system. * Signed informed consent provided by the participant or a trusted representative (for patients). For all TBI Participant * Hospitalized for a non-penetrating traumatic brain injury (TBI) occurring within the last 30 days, with traumatic coma (Glasgow Coma Scale (GCS) \< 10 and motor score (M) \< 6) at hospital admission. * Sedative treatments discontinued for more than 48 hours. * Clinically stable (no hemodynamic, respiratory, or metabolic instability requiring specific interventions that contraindicate medical transfer to the imaging center). For the TBI-COMA Group: \- Severe TBI characterized by prolonged coma, defined as an initial GCS \< 10 with M \< 6, and no recovery of consciousness at inclusion (GCS \< 10 with M \< 6). For the TBI-REC Group: * Severe TBI characterized by prolonged coma, defined as an initial GCS \< 10 with M \< 6, with recovery of consciousness evidenced by simple command-following (GCS ≥ 10 with M = 6) at inclusion. * For Healthy Controls: Matched by age (± 2 years) and sex to patients in the TBI-COMA group. Exclusion Criteria: For All Participants: * Pregnant or breastfeeding women * Contraindications to MRI * Known allergy to the PET radiotracer or its excipients. * History of conditions affecting the dopaminergic system * Individuals under legal protection measures * Current treatment with dopaminergic agonists or antagonists. For Patients Only: * Coma due to causes other than TBI. * Decompressive craniectomy resulting in anatomical alterations incompatible with standardized image analysis (e.g., midline shift \> 2 cm). For Healthy Controls Only: * Women of childbearing potential without effective contraception. * Women unwilling to maintain effective contraception during the 30-day study period.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Coma, Post-Head Injury ocular motor apraxia, Cogan type traumatic brain injury

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • CHU de Toulouse

    RECRUITING

    Toulouse, France

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