NCT05450237|Enrolling By Invitation
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Sponsor study identifier
observational
500
1 country
1
Study Start
July 1, 2022
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, Multiple Sclerosis, Parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. The evaluation of certain domains may be more difficult so, specific assessment tools are necessary to analyze them.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2022
Actual (reported)July 1, 2022
Actual (reported)July 8, 2022
Actual (reported)July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
500 patients will be enrolled in the study. The aim is to monitor over time items such as lifestyle indicators, cognitive, functional, emotional abilities and anxiety in patients with various types of neurological damage through use of evaluation scales.
The main scales used are: * BDI II: evaluates depression during the last week; * STAI 1-2: evaluate state anxiety and trait anxiety. * TAS-20 is a 20-item questionnaire used to assess alexithymia. * FSS: evaluetes the severity of symptoms related to fatigue * MFIS: lists 21 items describing the effects of fatigue in relation to their frequency over a four-week period. * MSIS-29:evaluates the impact of multiple sclerosis on daily life taking into consideration a time interval of 14 days. * ESS: evaluates the likelihood of daytime sleepiness in certain situations, regardless of fatigue. * PSQI:investigates the quality of sleep over the past month. * MSQOL / 54: evaluates the impact of the disease on the quality of life. * WPAI: is a tool that measures the difficulties in work and daily activities due to illness.
These scales will be administered after certain time intervals. The results obtained will be compared in other to highlight a variation in the scores in the various items.The duration of administration of the scales is approximately one hour.
The main evaluation scales we will use are the Beck Depression Inventory-II (BDI II), the State-Trait Anxiety Inventory (STAI), The twenty-item Toronto Alexithymia scale- I (TAS-20), The fatigue severity scale (FSS), Modified Fatigue Impact Scale (MFIS), The Multiple Sclerosis Impact Scale (MSIS-29), The Epworth Sleepiness Scale (ESS) (Johns MW. 1991), The Pittsburgh Sleep Quality Index (PSQ1), The Multiple Sclerosis quality of life Inventory (MSQOLI), The work productivity and activity impairment instrument (WPAI), Frailty Index. These rating scales will be administered in person, by telephone and / or by sending them electronically.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients in follow-up at IRCSS Neuromed in Pozzilli (IS).
Ircss Neuromed
Pozzilli, Isernia, 86077, Italy
Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Centonze
IRCSS Neuromed
First Submitted
July 1, 2022
First Posted
July 8, 2022
Study Start
July 1, 2022
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Contact the study team to confirm eligibility.
Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001 May;124(Pt 5):962-73. doi: 10.1093/brain/124.5.962.
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019.
Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 16, 2024
Record last verified: 2024-10
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