Fatigue Following Moderate and Severe TBI

NCT03597763 | Completed

• 1 other identifier: 2018/FO202360
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Traumatic Brain Injury; Fatigue

Keywords

persistent fatigue; traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Giessen Symptoms Checklist - fatigue subscale

  12 months post-injury

Other Outcomes (28)

• 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

Study Arms (1)

Moderate to severe traumatic brain injury

Patients who have suffered a moderate to severe traumatic brain injury, with confirmed intracranial damage.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Moderate or severe TBI (assessed by a Glasgow Coma Scale between 3-13 within the first 24 hours post-injury, and a radiologically confirmed intracranial injury)
• Patients from the Eastern part of Norway.

You may not qualify if:

• Pre- or comorbid neurological, medical or severe psychological disorders with the potential to cause fatigue.
• Ongoing substance abuse
• Cognitive or physical impairments to such a degree that neuropsychological assessment and self-report measures cannot be adequately applied.

Sponsors & Collaborators

• University of Oslo: lead
• Extrastiftelsen: collaborator
• Sunnaas Rehabilitation Hospital: collaborator
• Personskadeforbundet LTN: collaborator
• Oslo University Hospital: collaborator

Study Sites (2)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1453, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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).

MeSH Terms

Conditions

Brain Injuries, Traumatic; Fatigue

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johan K. Stanghelle, Professor dr. med.

  Sunnaas Rehabilitation Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist / PhD-candidate

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 24, 2018
• Study Start: March 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

NO (2)