Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury (INSPIRE-TC)

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury (TBI)
• Intervention / Treatment: Other: MRI scan and endocrinology analysis

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône Alpes
    • Lyon, Rhône Alpes, France, 69000
      • Recruiting
      • French University Hospital
      • Principal Investigator: sophie Courtois, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Patients With Traumatic Brain Injury; 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; Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.; Other Names: MRI scan; endocrinology analysis

What is the study measuring?

Primary Outcome Measures

Outcome 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 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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sophie Courtois, MD, Hôpital Henry Gabrielle, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: January 15, 2012
• First Posted (ESTIMATE): January 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Quality of Life (QoL); hypopituitarism,GH
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2010.641