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

Primary Purpose

Traumatic Brain Injury (TBI)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI scan and endocrinology analysis
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury (TBI) focused on measuring Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • French University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients With Traumatic Brain Injury

Arm Description

Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma.

Outcomes

Primary Outcome Measures

Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma

Secondary Outcome Measures

QOLIBRI (Quality of Life after Brain Injury) measure #1
Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2
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)
Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score
Functional outcome #5 :the Functional Independence Measure (FIM)

Full Information

First Posted
December 29, 2011
Last Updated
March 21, 2014
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01512524
Brief Title
Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI)
Keywords
Traumatic Brain Injury, Quality of Life (QoL), hypopituitarism,GH

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients With Traumatic Brain Injury
Arm Type
Other
Arm Description
Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma.
Intervention Type
Other
Intervention Name(s)
MRI scan and endocrinology analysis
Other Intervention Name(s)
MRI scan, endocrinology analysis
Intervention Description
Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
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.
Title
Tests of Attentional, mnesic and executive performances #3
Description
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Villeneuve
Phone
+33 4 78 86 45 33
Email
laurent.villeneuve@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy Falgon
Phone
+33 4 78 86 45 33
Email
peggy.falgon@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Courtois, MD
Organizational Affiliation
Hôpital Henry Gabrielle, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
French University Hospital
City
Lyon
State/Province
Rhône Alpes
ZIP/Postal Code
69000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sophie Courtois, MD

12. IPD Sharing Statement

Learn more about this trial

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

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