Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury (INSPIRE-TC)
|ClinicalTrials.gov Identifier: NCT01512524|
Recruitment Status : Unknown
Verified March 2014 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : January 19, 2012
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury (TBI)||Other: MRI scan and endocrinology analysis||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2011|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
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.
- 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. ]
- 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. ]
- 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. ]
- 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. ]
Tests of Attentional, mnesic and executive performances: - Alertness
- Sustained Attention
- Divided Attention
- Working Memory
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512524
|Contact: Laurent Villeneuve||+33 4 78 86 45 email@example.com|
|Contact: Peggy Falgon||+33 4 78 86 45 firstname.lastname@example.org|
|French University Hospital||Recruiting|
|Lyon, Rhône Alpes, France, 69000|
|Principal Investigator: sophie Courtois, MD|
|Principal Investigator:||Sophie Courtois, MD||Hôpital Henry Gabrielle, Hospices Civils de Lyon|