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

Hospices Civils de Lyon88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury (TBI)

Interventions

MRI scan and endocrinology analysisOTHER

Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

French University Hospital

Lyon, Auvergne-Rhône-Alpes, France

Outcomes

Primary Outcomes

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.

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

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)

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.

Data from ClinicalTrials.gov

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