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

NCT01512524 | Completed DMC

• 1 other identifier: 2010.641
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury (TBI)

Keywords

Traumatic Brain Injury; Quality of Life (QoL); hypopituitarism,GH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• 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.

Study Arms (1)

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.

Other: MRI scan and endocrinology analysis

Interventions

MRI scan and endocrinology analysis OTHER

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

Also known as: MRI scan, endocrinology analysis

Patients With Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

French University Hospital

Lyon, Auvergne-Rhône-Alpes, 69000, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sophie Courtois, MD

  Hôpital Henry Gabrielle, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 19, 2012
• Study Start: November 23, 2011
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)