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Fatigue Following Moderate and Severe TBI

NCT03597763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2021-05-28

No results posted yet for this study

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

Sponsors & Collaborators

  • Extrastiftelsen

    collaborator OTHER

  • Sunnaas Rehabilitation Hospital

    collaborator OTHER

  • Personskadeforbundet LTN

    collaborator UNKNOWN

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    lead OTHER

Principal Investigators

  • Johan K. Stanghelle, Professor dr. med. · Sunnaas Rehabilitation Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597763 on ClinicalTrials.gov