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

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).

Traumatic Brain Injury

Fatigue

Sunnaas Rehabilitation Hospital

Oslo University Hospital

Fatigue Following Moderate and Severe TBI

Development of Persistent Fatigue Following Moderate and Severe Traumatic Brain Injury - Exploration of General and Injury-specific Mechanisms.

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.

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.

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".

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.

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.

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.

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.

Subjective reporting of pain-afflicted regions of the body, used to assess extent of pain.

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.

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.

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.

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.

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.

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).

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.

Neuropsychological test of verbal abstraction abilities.

Neuropsychological test of visual abstraction abilities and general intelligence.

Neuropsychological test of verbal comprehension and general intelligence.

Neuropsychological test of auditory attention and working memory.

Neuropsychological test of sustained attention, vigilance and impulsivity

Neuropsychological test of psychomotor speed and divided attention.

Neuropsychological test of psychomotor speed, divided attention and impulse inhibition.

Neuropsychological test of decision making and reward/punishment sensitivity.

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.

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.

Abbreviated research edition of the standardized inventory, used to assess depression and anxiety symptoms.

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.

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.

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.

Daniel Løke

Psychologist / PhD-candidate

University of Oslo

Extrastiftelsen

Personskadeforbundet LTN

All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.

All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).

Study Group

Gender

Race (NIH/OMB)

Region of Enrollment

Assesses the ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.

PROMIS Physical Functioning

Sleep efficiency is defined as the ratio of time sleeping and time in bed. Using a sleep diary, participants recorded bedtime the night before, amount of time it took to fall asleep, number and total duration of awakenings, time of final awakening, and time of rising. Efficiency ranges from 0 to 100; higher values indicate higher sleep efficiency or more time sleeping when in bed.

Subjective sleep efficiency

Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities.Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.

PROMIS Fatigue

Refers to cumulative steps per day (24 hours period). 10,000 or more steps per day is considered optimal.

Physical activity, number of steps daily

Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.

PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning

The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.

All subjects took a three month trials of 1,000 mg of glutathione supplement

Sleep Efficiency

Count of steps per day using activity monitor worn on upper arm.

Steps Per Day

Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.

PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue

Overall Study

Claire Z. Kalpakjian

Post-polio Syndrome

Physical Activity

Depression

Pain

Sleep Disorders

glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.

poliomyelitis/fatigue

Fatigue Following Moderate and Severe TBI

Glutathione and Health With Post-Polio Syndrome

Study of "Post-Polio Syndrome"

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