Loading search results
Development of Persistent Fatigue Following Moderate and Severe Traumatic Brain Injury - Exploration of General and Injury-specific Mechanisms.
Sponsor study identifier
observational
104
1 country
2
Study Start
March 1, 2018
Actual (reported)Primary Completion
April 30, 2021
Actual (reported)Study Completion
April 30, 2021
Actual (reported)The subjective feeling of being periodically fatigued, tired, even exhausted is common in the general population, as well as in a large number of medical conditions, including neurological illness, such as traumatic brain injury (TBI), cerebrovascular accidents (CVA), multiple sclerosis (MS), and poliomyelitis. Fatigue typically results in compensatory behaviors such as spending extended time in bed, daytime napping, and restricted participation in activities of daily living, which in turn can have a profound negative impact on mental and physical health. Although fatigue is common and debilitating, there is a scarcity of knowledge concerning underlying biological, psychological and psychosocial mechanisms in the development and maintenance of persisting fatigue. There is also a general lack of theoretical accounts of potentially shared and etiology-specific mechanisms across conditions. The existence of clinical subgroups and diverse clinical trajectories is not well documented, resulting in a lack of evidence-based treatment opportunities. Diagnosis and management of fatigue is further challenged by difficulties in conceptualizing and defining the phenomenon itself, since fatigue is subjectively experienced and multifaceted. Thus, as fatigue often poses a chronic problem, health professionals in community based rehabilitation settings are faced with helping patients cope with this symptom without a clear understanding of causes or treatment options. The current project aims to map the occurrence of fatigue following moderate to severe TBI and achieve a better theoretical and clinical understanding of the mechanisms which may cause, exacerbate or protect against persisting fatigue following TBI. The study approach acknowledges that fatigue after neurological illness is the result of complex interplays between general individual predispositions and etiology-specific factors. A better understanding of these mechanisms is a prerequisite for personalized treatment and development of empirically based randomized controlled intervention studies. This approach has relevance to other clinical conditions as well. The long-term aim is to ensure accurate diagnosis, improve treatment and rehabilitation, and to contribute to knowledge based clinical decision-making both within specialized and community based rehabilitation settings.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2018
Actual (reported)July 2, 2018
Actual (reported)July 24, 2018
Actual (reported)April 30, 2021
Actual (reported)April 30, 2021
Actual (reported)Fatigue Severity Scale
A validated self-report questionnaire with norms available for the general Norwegian population, measuring primarily subjectively experienced functional consequences of fatigue. The scale provides a total average score of the nine Likert items ranging between 1-7, where 1 indicates little to no experienced functional limitations due to fatigue, and 7 indicates severe experienced functional limitations due to fatigue. The norms provide t-scores corrected for age, education and gender.
12 months post-injury
Chalder Fatigue Questionnaire
A validated self-report questionnaire with norms available for the general Norwegian population, with subscales for both mental and physical fatigue. The scale provides sum scores of mental (4 items), physical (7 items) and total fatigue, with individual items administered ranging between 0-3. High sum scores indicate higher degree of subjective fatigue. Norms provide t-scores corrected for gender and age on both subscales and the total score. In addition to the 11 items used to compute the subscale scores and the total score, two additional items address the longevity and extent of the subjective fatigue on a range between 0-3, where higher scores indicate longer duration of and more severe extent of the subjective fatigue problems.
12 months post-injury
Giessen Symptoms Checklist - fatigue subscale
12 months post-injury
Giessen Symptoms Checklist
6 and 12 months post-injury
Insomnia Severity Index
6 and 12 months post-injury
Epworth Sleepiness Questionnaire
6 and 12 months post-injury
Patients who have suffered a moderate to severe traumatic brain injury, with confirmed intracranial damage.
The study sample will be identified through the collaboration with the Neurosurgical department at Ullevål, Oslo University Hospital (OUH), where the majority of patients in the Eastern part of Norway with moderate to severe traumatic brain injuries are admitted. Patients within our eligibility criteria are referred to Department of Physical Medicine and Rehabilitation at Ullevål, OUH. Some eligible patients not admitted to the Neurosurgical department, are routinely referred from other hospitals to Sunnaas Rehabilitation Hospital or Department of Physical Medicine and Rehabilitation at Ullevål, OUH. Patients are informed about the project by clinicians, and if they consent, the primary investigator contacts them to inform more thoroughly about the project. Patients who have been identified, but who do not arrive at clinical appointments, are sent an informational letter with an invitation to the project, with contact information.
Sunnaas Rehabilitation Hospital
Nesoddtangen, Akershus, 1453, Norway
Oslo University Hospital
Oslo, 0424, Norway
Biological data will include standard blood test screening during hospitalization and 6 months follow-up, including tests to rule out other causes of fatigue: kidney, liver, thyroidal and pituitary status, haemoglobin, cortisol, B-12, D-vitamins and C-reactive protein (CRP).
Johan K. Stanghelle, Professor dr. med.
Sunnaas Rehabilitation Hospital
104 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2018
First Posted
July 24, 2018
Study Start
March 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 30, 2021
Actual (reported)Study Completion
April 30, 2021
Actual (reported)Last Updated
May 28, 2021
Record last verified: 2021-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: