ClinicalTrials.gov
ClinicalTrials.gov Menu

Fatigue Following Moderate and Severe TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03597763
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Extrastiftelsen
Sunnaas Rehabilitation Hospital
Personskadeforbundet LTN
Oslo University Hospital
Information provided by (Responsible Party):
Daniel Løke, University of Oslo

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.

Condition or disease
Traumatic Brain Injury Fatigue

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Persistent Fatigue Following Moderate and Severe Traumatic Brain Injury - Exploration of General and Injury-specific Mechanisms.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: 12 months post-injury ]
    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.

  2. Chalder Fatigue Questionnaire [ Time Frame: 12 months post-injury ]
    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.


Secondary Outcome Measures :
  1. Giessen Symptoms Checklist - fatigue subscale [ Time Frame: 12 months post-injury ]
    Subscale of the questionnaire measuring subjectively experienced fatigue, which provides an average score using six symptom items and reported symptom distress on a scale between 0-4 for both "in general" and "in the last two days".


Other Outcome Measures:
  1. Giessen Symptoms Checklist [ Time Frame: 6 and 12 months post-injury ]
    Self-reported subjective somatic symptom complaints. The questionnaire consists of 25 symptoms, and respondents are asked to rate the presence of each symptom on a scale of 0-4 "in general" and "in the last two days", thus providing a total of 50 responses. The responses provide average scores for the subscales of fatigue, gastrointestinal symptoms, musculoskeletal symptoms, cardio-vascular symptoms and a total average of subjective symptom distress.

  2. Insomnia Severity Index [ Time Frame: 6 and 12 months post-injury ]
    Self-reported sleep disturbances. The questionnaire consists of seven items rated on a scale of 0-4, where a higher sum score indicates more severe sleep disturbances.

  3. Epworth Sleepiness Questionnaire [ Time Frame: 6 and 12 months post-injury ]
    Self-reported sleepiness. The questionnaire consists of eight items rated on scale of 0-3, where a higher sum score indicates higher severity of problems relating to sleepiness.

  4. The Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: 6 and 12 months post-injury ]
    Self-report questionnaire assessing behavioral inhibition and activation traits. The questionnaire provides separate sum scales for Behavioral Activation (13 items) and its subscales Reward Responsiveness (5 items), Fun Seeking (4 items) and Drive (4 items), and a total sum score for Behavioral Inhibition (7 items). Each item is rated by the respondent on a scale between 1-4.

  5. Pain drawing [ Time Frame: 6 and 12 months post-injury ]
    Subjective reporting of pain-afflicted regions of the body, used to assess extent of pain.

  6. Four NRS items on pain intensity [ Time Frame: 6 and 12 months post-injury ]
    Four NRS items ranging 0-10 questioning namely the strongest and weakest pain intensity within the two last weeks, pain intensity in general, and pain intensity presently.

  7. NEO Five Factor Inventory 3 [ Time Frame: 6 and 12 months post-injury ]
    Personality assessment questionnaire, providing t-scores for the personality traits Openness, Conscientiousness, Agreeableness, Extroversion and Neuroticism. Respondents answer items ranging between 0-4, and sum scores are converted into scaled t-scores using the official norms corrected for gender.

  8. Quality of Life after Brain Injury [ Time Frame: 6 and 12 months post-injury ]
    Questionnaire specifically developed to measure fatigue in patients with acquired brain injury. The questionnaire provides scores for quality of life with regards to cognition (7 items), perception of self (7 items), daily life & autonomy (7 items), social relations (6 items), emotional status (5 items) and physical problems (5 items), as well as a total score (37 items). The average subscale and total scores are recalculated to a scale ranging between 0 and 100, where lesser scores indicate reduced quality of life.

  9. Life Orientation Test Revised - Optimism subscale [ Time Frame: 6 and 12 months post-injury ]
    Six selected items from the Optimism subscale to measure optimism as a trait, where individual items are rated on a scale of 0-4, and a higher average score indicates a higher degree of trait optimism.

  10. University of California in Los Angeles (UCLA) Loneliness Scale [ Time Frame: 6 and 12 months post-injury ]
    Three selected items from the questionnaire, where individual items are rated on a scale of 0-4, where a higher average scores indicate a higher degree of loneliness.

  11. Rivermead Post-Concussion Questionnaire [ Time Frame: 6 and 12 months post-injury ]
    Self-reported common somatic, emotional and cognitive symptoms following head injury, rated on a scale of 0-4, where 0 = no problems, 1 = symptom no longer a problem, and the ratings of 2-4 indicating higher degree of symptom burden. Sum scales are calculated for responses in the range 2-4 on the subscales of somatic (9 items), emotional (4 items) and cognitive (3 items) symptoms, as well as a scale for total symptom burden (16 items).

  12. Resilience Scale for Adults [ Time Frame: 6 and 12 months post-injury ]
    Self-report measure of various resilience factors. The questionnaire consists of 33 items rated on a scale between 1-5, with sum scores provided for the subscales Self Perception (6 items), Future Perception (4 items), Social Competence (6 items), Family Cohesion (6 items), Social Resources (7 items) and Structured Style (4 items), where higher sum scores indicate a higher degree of resilience.

  13. Wechsler Abbreviated Scale of Intelligence (WASI) subtest - Similarities [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of verbal abstraction abilities.

  14. Wechsler Abbreviated Scale of Intelligence (WASI) subtest - Matrix Reasoning [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of visual abstraction abilities and general intelligence.

  15. Wechsler Abbreviated Scale of Intelligence (WASI) subtest - Vocabulary [ Time Frame: 12 months post-injury ]
    Neuropsychological test of verbal comprehension and general intelligence.

  16. Wechsler Adult Intelligence Scale IV (WAIS-IV) subtest - Digit span [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of auditory attention and working memory.

  17. Conners' Continuous Performance Test 3 [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of sustained attention, vigilance and impulsivity

  18. Delis-Kaplan Executive Function System (D-KEFS) subtest - Trail Making Test [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of psychomotor speed and divided attention.

  19. Delis-Kaplan Executive Function System (D-KEFS) subtest - Color Word Interference Test [ Time Frame: 6 and 12 months post-injury ]
    Neuropsychological test of psychomotor speed, divided attention and impulse inhibition.

  20. Iowa Gambling Task 2 [ Time Frame: 12 months post-injury ]
    Neuropsychological test of decision making and reward/punishment sensitivity.

  21. Cut Down, Annoyed, Guilty and Eye opener (CAGE) [ Time Frame: 6 and 12 months post-injury ]
    Alcohol abuse screening tool consisting of four items where respondents are asked to indicate Yes or No to risk factors for alcohol abuse, with a sum score ranging between 0-4, where a higher score indicates higher risk of abuse. For this research project, additional questions are asked about whether these risk factors were also present premorbid to the injury.

  22. Cut Down, Annoyed, Guilty and Eye opener, Adapted to Include Drugs (CAGE-AID) [ Time Frame: 6 and 12 months post-injury ]
    Drug abuse screening tool consisting of four items where respondents are asked to indicate Yes or No to risk factors for drug abuse, with a sum score ranging between 0-4, where a higher score indicates higher risk of abuse. For this research project, additional questions are asked about whether these risk factors were also present premorbid to the injury.

  23. Hopkins Symptoms Checklist 8 [ Time Frame: 6 and 12 months post-injury ]
    Abbreviated research edition of the standardized inventory, used to assess depression and anxiety symptoms.

  24. Negative Life Events Questionnaire [ Time Frame: 6 and 12 months post-injury ]
    Self-reported negative life events last 12 months before injury, the first six months post-injury, and in the period between 6-12 months post-injury. Respondents are asked to indicate the presence or abscence of each of the 12 negative life events in these time periods, which provides a sum score of severe life events.

  25. Two Numerical Rating Scale items about fatigue [ Time Frame: 6 and 12 months post-injury ]
    One NRS item administered in advance of neuropsychological assessment (point 1), and one following assessment (point 2). The NRS items range between 1-10, where lower scores indicate a lower degree of experienced fatigue. Difference scores are computed by subtracting point 1 from point 2, and is used to measure perception of fatigability in the test situation.

  26. Glasgow Outcome Scale Extended [ Time Frame: 6 and 12 months post-injury ]
    Interview for categorizing functional outcome following traumatic brain injury. The interview provides a total score between 1-8, with the following categories: 1 = dead, 2 = Vegetative state, 3 = Severe disability, lower level, 4 = Severe disability, higher level, 5 = Moderate disability, lower level, 6 = Moderate disability, higher level, 7 = Good restitution, lower level, 8 = Good restitution, higher level.

  27. Fatigue Severity Scale [ Time Frame: 6 months post-injury ]
    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.

  28. Chalder Fatigue Questionnaire [ Time Frame: 6 months post-injury ]
    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.


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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03597763


Contacts
Contact: Daniel Løke, cand. psychol. 40328473 ext +47 dloeke@gmail.com
Contact: Marianne Løvstad, PhD 93452003 ext +47 mar.lovstad@gmail.com

Locations
Norway
Sunnaas Rehabilitation Hospital Recruiting
Nesoddtangen, Akershus, Norway, 1453
Contact: Daniel Løke, cand.psychol.    40328473 ext +47    danloe@sunnaas.no   
Principal Investigator: Daniel Løke, cand.psychol.         
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Daniel Løke, cand.psychol.    40328473 ext +47    danloe@ous-hf.no   
Principal Investigator: Daniel Løke, cand.psychol.         
Sponsors and Collaborators
University of Oslo
Extrastiftelsen
Sunnaas Rehabilitation Hospital
Personskadeforbundet LTN
Oslo University Hospital
Investigators
Study Chair: Johan K. Stanghelle, Professor dr. med. Sunnaas Rehabilitation Hospital

Responsible Party: Daniel Løke, Psychologist / PhD-candidate, University of Oslo
ClinicalTrials.gov Identifier: NCT03597763     History of Changes
Other Study ID Numbers: 2018/FO202360
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Løke, University of Oslo:
persistent fatigue
traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Fatigue
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms