Brain scans reveal dopamine disruption in coma patients
NCT ID NCT06930261
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for COMA are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGToulouse, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can brainwave and blood flow data forecast who wakes after a severe brain injury?
- Could a new suction technique help comatose patients breathe easier?
- Ear-Clip nerve zaps may wake hidden awareness after brain injury
- Brain seizures after cardiac arrest: can early treatment save lives?
- Gut-Brain link after severe head injury: a new clue to preventing further damage
- Brain wiring maps may forecast coma recovery after cardiac arrest