Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation

NCT05450237 | Enrolling By Invitation

• 1 other identifier: Punto 5 O.d.g. 30.06.2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Epilepsy; Parkinson Disease; Dementia; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Psychometric Evaluations BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in follow-up at IRCSS Neuromed in Pozzilli (IS).

You may qualify if:

• 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.

You may not qualify if:

• Inability, even partial, to understand and want;
• Patients with other pathologies that in the opinion of the scientific responsible prevent their recruitment

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Ircss Neuromed

Pozzilli, Isernia, 86077, Italy

Location

Related 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.

  PMID: 8126686 RESULT

• 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.

  PMID: 2748771 RESULT

• 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.

  PMID: 11335698 RESULT

• 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.

  PMID: 1798888 RESULT

• 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.

  PMID: 2803071 RESULT

• 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.

  PMID: 24453758 RESULT

• 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.

  PMID: 12806071 RESULT

• 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.

  PMID: 10146874 RESULT

• 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.

  PMID: 7613530 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Epilepsy; Parkinson Disease; Dementia; Stroke

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Centonze

  IRCSS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 8, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

IT (1)