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Brain injury study reveals hidden hormone link to Long-Term wellbeing

NCT ID NCT01512524

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 88 adults with moderate to severe traumatic brain injury for up to 18 months. Researchers used MRI scans and hormone tests to see if hormone deficiencies after injury are linked to lower quality of life. The goal was to better understand these connections, not to test a new treatment.

What this could mean

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

What this could lead to
If successful, this could help doctors understand why some TBI patients have long-term quality-of-life issues and point toward better monitoring or support.
What could go wrong
This is an observational study with no treatment being tested, so it won't directly improve patient outcomes. Results may not apply to all TBI 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

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

88 people

The number who actually took part.

Started

Nov 2011

Finished

May 2017

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

18 to 65 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: * All subjects must be between the ages of 18-65 * Documented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury. * Glasgow Coma Scale (GCS) equal to or greater than 12 * Patients volunteer to participate in the study, with a written informed consent signed * BMI between 17 kg/m2 - 30kg/m2 * Affiliation to a national health insurance program Exclusion Criteria: * Glasgow Coma Scale (GCS) ≥13 * History of TBI ≥4 months * Anterior hypopituitarism documented * History of radiotherapy * Liver dysfunction: total bilirubin \<20µmol/l and/or factor V\<60%) * Renal dysfunction: creatinine clearance \< 30 ml/mn (Cockcroft \& Gault) * Anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI * Pregnancy * Contraindications to MRI: * Patients who have a heart pacemaker * Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain * Patients with severe claustrophobia

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury (TBI)

Contacts and locations

Locations

  • French University Hospital

    Lyon, Auvergne-Rhône-Alpes, 69000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.