Association of Chronic Posttraumatic Fatigue and Pituitary Hormone Deficiencies after Traumatic Brain Injury
- Conditions
- persisternde cognitieve en fysieke vermoeidheid na letselfatiguetraumatic brain injury1002111210042258
- Registration Number
- NL-OMON32656
- Lead Sponsor
- Revalidatiecentrum Groot Klimmendaal Arnhem en ziekenhuis Rijnstate Arnhem
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion criteria
* Patients treated in the TBI department of the rehabilitation centre of
Groot Klimmendaal between 2000 and 2008
* Males and females age 18 to 50 years.
* Confirmed diagnosis of previous TBI of at least one year
-TBI that required hospitalization
-originally diagnosed by neurological assessment and MRI or CT
-Extended Glasgow Coma Scale at time of inclusion >=5
* Subjects who are willing and able to comply with scheduled visits and
laboratory tests.
* Evidence of a personally signed and dated informed consent document
indicating that the subject or a legally acceptable representative has
been informed of all pertinent aspects of the trial.
Exclusion criteria
* Hypothalamic/pituitary disease diagnosed prior to TBI
* Brain injury of non traumatic origin
* History of cranial irradiation
* Known drug or alcohol abuse
* Present or past non-TBI related medical (diagnosed by a medical
specialist) or psychiatric conditions (according to DSM IV criteria) that
impair the fulfilment of study requirements and/or interfere with the
evaluation of study objectives by probable independent effects on quality
of life or neuropsychological functioning.
* Severe neuromuscular disability or additional co-morbidity (heart,
pulmonary, kidney, and liver disease) which causes such a condition
deficit that it is impossible to fulfil the physical condition Åstrand test by
bike.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters<br /><br>fatigue score (CIS20R Sub), </p><br>
- Secondary Outcome Measures
Name Time Method <p>Severity of TBI (GOSE), demographic questionnaire, Cognition (TOSSA,TODA),<br /><br>emotion and depression (HADS), general quality of life in TBI (QOLIBRI),<br /><br>hypogonadism score (AMS), growth hormone deficiency related quality of life<br /><br>(AGHDA-QOL), acceptance and coping (AAQ), sleep quantity and quality (Sleep<br /><br>Q.), physical activity score ( FAI), physical performance (Åstrand), serum<br /><br>hormone levels measured between 8.00 h and 10.00h AM (free T4, T3, TSH,<br /><br>cortisol, ACTH, prolactin, sex hormones, SHBG, IGF-I, IGF-BP3), and the maximal<br /><br>GH response to the growth-hormone releasing hormone-Arginine test (GHRH-Arg),<br /><br>body composition by dual energy X-ray absorptiometry.<br /><br><br /><br>7 variables (cognition, emotional state, coping-acceptance state, condition,<br /><br>sleep quality/quantity, activity state, hormonal state will be used tot<br /><br>determine their contribution to the chronic post TBI fatigue.</p><br>