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

Traumatic Brain Injury (TBI) Clinical Trial

— INSPIRE-TC  

Official title:

Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01512524
• Other study ID #: 2010.641
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2011
• Last updated: March 21, 2014
• Start date: November 2011
• Est. completion date: December 2017

Study information

• Verified date: March 2014
• Source: Hospices Civils de Lyon
• Contact: Laurent Villeneuve
• Phone: +33 4 78 86 45 33
• Email: laurent.villeneuve[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury (TBI)

Intervention

Other:
• MRI scan and endocrinology analysis
Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.

Locations

Country	Name	City	State
France	French University Hospital	Lyon	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	QOLIBRI (Quality of Life after Brain Injury) measure #1		assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score		assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.	No
Secondary	Functional outcome #5 :the Functional Independence Measure (FIM)		assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.	No