Traumatic Brain Injury (TBI)INSPIRE-TCNCT01512524
Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury
A study testing MRI scan and endocrinology analysis in people with Traumatic Brain Injury (TBI), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- MRI scan and endocrinology analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2011to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life
The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.
Read the detailed description
Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.
Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.
The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- MRI scan and endocrinology analysis
- Keywords
- Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan and endocrinology analysisOther
Also called MRI scan, endocrinology analysis
Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Traumatic Brain Injury | Other | Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma. Receives: Other: MRI scan and endocrinology analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma
Measured: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Secondary outcomes (5)
QOLIBRI (Quality of Life after Brain Injury) measure #1
Measured: assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.
Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2
Measured: Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Tests of Attentional, mnesic and executive performances #3
Tests of Attentional, mnesic and executive performances: - Alertness
- Sustained Attention
- Divided Attention
- Go/NoGo
- Working Memory
- Incompatibility
- Flexibility
- Grober and Buschke test
- Rey's complex figure (copy and memory)
Measured: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score
Measured: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Functional outcome #5 :the Functional Independence Measure (FIM)
Measured: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study start23 Nov 2011
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Courtois, MD, Principal investigator, Hôpital Henry Gabrielle, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512524
- Sponsor's protocol ID
- 2010.641
- Acronym
- INSPIRE-TC
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2011
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life
- ClinicalTrials.gov ID
- NCT01512524
- Acronym / sponsor ID
- INSPIRE-TC / 2010.641
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2011 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.
Detailed description
Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.
Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.
The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Traumatic Brain Injury | Other | Other: MRI scan and endocrinology analysisStudy of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scan and endocrinology analysisAlso: MRI scan, endocrinology analysisEndocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan. | Other | Patients With Traumatic Brain Injury |
Primary outcome
Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma
Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
5 secondary outcomes
QOLIBRI (Quality of Life after Brain Injury) measure #1
Time frame: assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.
Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2
Time frame: Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Tests of Attentional, mnesic and executive performances #3
Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score
Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Functional outcome #5 :the Functional Independence Measure (FIM)
Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Courtois, MD principal investigator
Hôpital Henry Gabrielle, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan and endocrinology analysis in people with Traumatic Brain Injury (TBI), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma (time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.