Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation (NeuroPsyc)

Stroke Clinical Trial

— NeuroPsyc  

Official title:

Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05450237
• Other study ID #: Neurology01_2022
• Status: Enrolling by invitation
• Start date: May 18, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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 presence of cognitive deficits in the sphere of memory or language is often evident at a first clinical examination. However, the evaluation of certain domains such as mood disorders, behavior, sleep-wake cycle or eating habits, may be less evident, even if they have a very strong impact on the quality of life of patients. Specific assessment tools are therefore needed such as psychometric tests, to collect information and analyze the results.

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), 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: June 1, 2025
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Presence of brain damage resulting from: Multiple Sclerosis, Parkinson's Disease, Dementia, head trauma, neurosurgery, Stroke, Epilepsy or other neurological syndromes (for the experimental group only);

• Be able to perform the tests to be administered for the duration of the study;

• Patients must be able to follow protocol directions throughout the study;

• Patients must be able to understand the purpose of the study;

• Signature of informed consent, approved by our Ethics Committee.

Exclusion Criteria:

• Inability, even partial, to understand and want;

• Patients with other pathologies that in the opinion of the scientific responsible prevent their recruitment

Related Conditions & MeSH terms

• Brain Injuries
• Dementia
• Epilepsy
• Multiple Sclerosis
• Parkinson Disease
• Stroke

Intervention

Behavioral:
• Psychometric Evaluations
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.

Locations

Country	Name	City	State
Italy	Ircss Neuromed	Pozzilli	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.