Clinical trial NCT05450237: Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation
Official title: Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Epilepsy
Parkinson Disease
Dementia
Stroke
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in follow-up at IRCSS Neuromed in Pozzilli (IS).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: Ircss Neuromed
state: Isernia
Study officials:
affiliation: IRCSS Neuromed
name: Centonze
role: PRINCIPAL_INVESTIGATOR
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