Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life

Conditions
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Traumatic Brain Injury (TBI)

Intervention / Treatment
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* Other: MRI scan and endocrinology analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients With Traumatic Brain Injury<br>Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma. | Other: MRI scan and endocrinology analysis<br>* Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.<br>* Other names: endocrinology analysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma |  | assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOLIBRI (Quality of Life after Brain Injury) measure #1 |  | 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: 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) | assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. | 
| Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score |  | assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. | 
| Functional outcome #5 :the Functional Independence Measure (FIM) |  | assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH