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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01512524
First received: December 29, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Traumatic Brain Injury (TBI)
Other: MRI scan and endocrinology analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Tests of Attentional, mnesic and executive performances #3 [ Time Frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury. ] [ Designated as safety issue: No ]

    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)

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512524

Contacts
Contact: Laurent Villeneuve +33 4 78 86 45 33 laurent.villeneuve@chu-lyon.fr
Contact: Peggy Falgon +33 4 78 86 45 33 peggy.falgon@chu-lyon.fr

Locations
France
French University Hospital Recruiting
Lyon, Rhône Alpes, France, 69000
Principal Investigator: sophie Courtois, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sophie Courtois, MD Hôpital Henry Gabrielle, Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01512524     History of Changes
Other Study ID Numbers: 2010.641
Study First Received: December 29, 2011
Last Updated: March 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Traumatic Brain Injury
Quality of Life (QoL)
hypopituitarism,GH

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014