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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan and endocrinology analysis | Other | Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Courtois, MD | Hôpital Henry Gabrielle, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| French University Hospital | Lyon | Auvergne-Rhône-Alpes | 69000 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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|
| Tests of Attentional, mnesic and executive performances #3 | Tests of Attentional, mnesic and executive performances: - Alertness
| 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |