Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino
NCT02082002, Completed, Claudio Gobbi
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino | ClinicalTrials.gov |
| NCT number | NCT02082002 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 93 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Claudio Gobbi | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| First posted | 2014-03-07 | ClinicalTrials.gov |
| Last updated | 2019-03-21 | ClinicalTrials.gov |
Registered outcomes 38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Fatigue Severity Scale | 1 Day | a self-administered 9-items scale. The patient gives a score from 1 to 7 to each item. The resulting score is given as the mean value. Subjects with a score higher that 4 are considered fatigued. This scale assesses the impact of fatigue on multiple outcomes, with a physical focus. FSS has been validated for MS, it has an acceptable internal consistency, it is a reliable, completely safe and brief scale, which in addition has been shown to follow clinical changes in fatigue perception over time. Furthermore, FSS scores correlate with other commonly used fatigue scales, like the Modified Fatigue Impact Scale | ClinicalTrials.gov |
| Secondary | Modified Fatigue Impact Scale | 1 Day | a 21-items scale, which was proposed by the MS Council for Clinical Practice Guidelines as a shortened version of the previous 40-items Fatigue Impact Scale (21). The patient gives a score from 0 to 4 at each item, to express how every item best describes the personal experience, where 0 is "never" and 4 is "almost always"; the final score is the sum of the 21 items. The cut-off score beyond whom the subject can be considered fatigued is 38. The administration time is approximately 5-10 minutes. The MFIS is a structured, reliable, self-report questionnaire that the patient can generally complete easily, with little or no intervention from an interviewer. It provides a multidimensional assessment of fatigue, considering its impact on physical (9 items), cognitive (10 items) and phychosocial (2 items) functioning in daily life. It has a good reproducibility and a strong correlation with FSS results | ClinicalTrials.gov |
| Secondary | Fatigue Scale for Motor and Cognitive functions | 1 Day | a validated questionnaire specifically developed for MS (22). It is a 20-items scales that allows graduation of fatigue severity, and separate evaluation of motor (10 items) and cognitive (10 items) fatigue components. The response pattern for each item consists in a five-point Likert scale; a total score higher than 43 indicates the presence of mild fatigue and the score increases proportionally to the severity of fatigue (\> 53: moderate; \>63 severe); the cut-off for both the cognitive and the motor subscales is 22. FSMC provides good reliability and correlates with both FSS and MFIS scores | ClinicalTrials.gov |
| Secondary | Visual analogue scale for fatigue | 1 Day | a simple and quick measure of the patient's instant perception of fatigue on him/herself. It is a measurement of the impression at the moment of the interview. It consists of a graphic 10 cm wide line with "no fatigue" at one end and "very severe fatigue" on the other and the subject is asked to place a cross at the point that best express his/her answer to the question "how do you feel in this moment?" | ClinicalTrials.gov |
| Secondary | Maintenance of wakefulness test | 1 Day | it objectively explores somnolence in terms of ability to remain awake in sleep- promoting environmental conditions. It has to be performed after a nocturnal PSG recording because the knowledge of the previous sleep is essential for MWT interpretation. Recordings include only EEG, EMG and EOG from the previous PSG and are carried out in a dim room, with slight illumination. Patients are instructed to stay awake as long as possible. Four sessions are recorded every two hours, each lasting until the patient falls asleep or for 40 minutes of continuous awake state. The sleep latency is assessed in each of the four recordings and it is defined by the elapse time in minutes on each trial before sleep onset: the patient is considered asleep after three 30 seconds EEG epochs of stage N1 of non-REM sleep, or one 30-second epoch of any other sleep stage. | ClinicalTrials.gov |
| Secondary | Epworth Sleepiness Scale | 1 Day | a self-administered questionnaire with 8 questions, which provide a measure of a subject's general level of daytime sleepiness (26). Subjects are required to indicate their chance to fall asleep in 8 different situations on a rating scale from 0 to 3, where 0 means no chance and 3 big chance. The total score is the sum of the eight items, and a score higher that 10 suggests an excessive daytime sleepiness, whose severity increases proportionally to the score. Most people can answer the questions with no assistance in less than 5 minutes. | ClinicalTrials.gov |
| Secondary | Visual analogue scale for somnolence | 1 Day | a simple and quick measure of the patient's instant perception of somnolence on him/herself. It is a measurement of the impression at the moment of the interview. It consists of a graphic 10 cm wide line with "no sleepiness" at one end and "very severe sleepiness" on the other and the subject is asked to place a cross at the point that best express his/her answer to the question "how do you feel in this moment?". | ClinicalTrials.gov |
| Secondary | Beck depression inventory II | 1 Day | a 21-item self-report of depressive symptomatology for individuals aged 13 to 80 years (32). It was developed to have clinical sensitivity for assessing depression criteria reported in the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) and intends to assess symptoms experienced in the 2 weeks prior to assessment, such as intense sadness, crying, or changes in sleep, appetite, or sexual interest. Items are on a 4-point scale ranging from 0 to 3, with a maximum score of 63. Higher total scores indicate more severe depression symptoms. Administration of the scale takes about 10 minutes. | ClinicalTrials.gov |
| Secondary | Mongomery Asberg Depression Rating Scale | 1 Day | is a 10-items questionnaire that is used to measure the core symptoms and cognitive features of clinical depression (33). An higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The subject has to be interviewed by a trained psychologist or psychiatrist. | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test | 1 Day | is a measure of attention and processing speed. It presents a series of nine symbols, each of which is paired with a single digit, labelled 1-9, in a key at the top of a sheet. The remainder of the page has a pseudorandomized sequence of the symbols and the subject must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds. | ClinicalTrials.gov |
| Secondary | Paced Auditory Serial Addition Test | 1 Day | is another measure of sustained attention and speed of information processing. The subject hears a series of single digit number from CD that are presented at the rate of one every 3 seconds in the first part of the test (PASAT 3"), or at the rate of one every 2 seconds in the second part (PASAT 2"). The subject is asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part and each part has a maximum of 60 correct answers. | ClinicalTrials.gov |
| Secondary | Stroop Test | 1 Day | evaluates sustained attention and some aspects of executive functions, such as the ability to elaborate relevant and irrelevant dimensions in parallel and to inhibit an automatic response while performing a task based on conflicting stimuli. The procedure comprised of three trials. In the first trial, the subject is instructed to read a list of word indicating colours printed in black ink as quickly as possible; in the second trial the subject is instructed to name the colour of strings of dots as quickly as possible; in the third trial (interference condition), the subject has to name the colours of the ink of words indicating conflicting colours as quickly as possible. Performance will assess by calculating the time required to name the items and the number of the errors. | ClinicalTrials.gov |
| Other | State-Trait Anxiety Inventory Form Y | 1 Day | is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndrome. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety. Administration of the questionnaire take about 10 minutes. | ClinicalTrials.gov |
| Other | SCID-I Disorders- Patient Edition | 1 Day | semi-structured interview for making the major DSM-IV Axis I diagnoses. It contains the following modules: Mood Episodes, Psychotic and Associated Symptoms, Psychotic Disorders, Mood Disorders, Substance Use Disorders, Anxiety Disorders, Somatoform Disorders, Eating Disorders, and Adjustment Disorder. Each criterion is coded as either ?,1,2, or 3 (?= inadequate information to code the criterion; 1= the symptom described in the criterion is clearly absent; 2= the threshold for the criterion is almost, but not quite, met; 3= the threshold for the criterion is just met.). | ClinicalTrials.gov |
| Other | Selective Reminding Test | 1 Day | assess verbal learning and delayed recall. It include a list of 12 words and uses six consecutive learning trials and a delayed trials A word recalled on two consecutive trials is considered to have a long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total sum of the words in LTS of all six trials is taken (SRT-LTS). If a word in LTS is consistently recalled on all subsequent trials, it is then scored as in Consistent Long Term Retrieval (CLTR). The total sum of the word in CLTR of all six trials is taken (SRT-CLTR). The Delayed Recall (SRT-D) is the total number of words recalled after the delayed period. | ClinicalTrials.gov |
| Other | 10/36 Spatial Recall Test | 1 Day | assess visuo-spatial learning and delayed recall. In the test, a checkerboard, with ten checkers arranged in a particular pattern, is shown to the subject for ten second. Then the subject is asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials and a delayed trials. The score is the number of correct responses for the three trials and a delayed recall trials (SPART-D). | ClinicalTrials.gov |
| Other | Word List Generation | 1 Day | explores verbal fluency on semantic stimulus by asking the subject to produce as many words as possible belonging to a semantic category within 90 seconds. The score is the number of correct words. | ClinicalTrials.gov |
| Other | Pittsburgh Sleep Quality Index | 1 Day | a self-rated questionnaire which differentiates "poor" from "good" sleepers by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction (27). Scoring of the answers is based on a 0 to 3 scale, where 3 reflects the negative extreme on the Likert Scale. The sum of the seven sub-scores generates the total score where 5 is the cut-off for distinguishing poor (higher) from good (lower) sleepers. The PSQI has internal consistency and a reliability coefficient (Cronbach's alpha) of 0.83 for its seven components. | ClinicalTrials.gov |
| Other | Psychomotor Vigilance Task | 1 Day | it is a sustained-attention, reaction-timed task that is easily used to test the speed with which subjects respond to a visual stimulus, by pressing a button (28). It has become a standard laboratory tool in a variety of experimental conditions and in the sleep lab it is commonly used to assess the effects of sleep restriction on sustained performance (29-31). The PVT is a simple task where the subject is placed in front of a monitor where a light randomly appears every few seconds for 10 minutes and is asked to press a button as soon as the light appears. The main measurement is to see how many times the button is not pressed when the light is on. The test gives a numerical measure of sleepiness by counting the number of lapses in attention. | ClinicalTrials.gov |
| Other | Multiple Sclerosis quality of life (MSQol-54) | 1 Day | it is one of the most widely used MS-specific health related quality of life, instruments (34). This questionnaire includes 54 items distributed into multi-item scales (Physical health, Physical role limitations, Emotional role limitations, Pain, Emotional well-being, Energy, Social function, Cognitive function, Health perception, Health distress, Overall quality of life, Sexual function) and two single items (Change in health, Sexual function satisfaction). Two summary scores-physical health composite and mental health composite can be derived from a weighted combination of scale scores. MSQol-54 scale scores will create using the Likert method by averaging items within the scales, and then row scores will be linearly transformed into 0-100 scales. Higher values indicate better quality of life. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Other outcome | ConductCognition |
| Selective Reminding Task | Other outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)