Traumatic Brain Injury (TBI)
Conditions
Keywords
Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH
Brief 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.
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.
Interventions
OTHERMRI scan and endocrinology analysis
Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. | 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) |
| 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. | — |
Countries
France
Outcome results
None listed