Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury (INSPIRE-TC)
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|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512524
|Contact: Laurent Villeneuve||+33 4 78 86 45 firstname.lastname@example.org|
|Contact: Peggy Falgon||+33 4 78 86 45 email@example.com|
|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|