Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation (NeuroPsyc)
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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. [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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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);
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Be able to perform the tests to be administered for the duration of the study;
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Patients must be able to follow protocol directions throughout the study;
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Patients must be able to understand the purpose of the study;
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Signature of informed consent, approved by our Ethics Committee.
Exclusion Criteria:
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Inability, even partial, to understand and want;
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Patients with other pathologies that in the opinion of the scientific responsible prevent their recruitment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ircss Neuromed | Pozzilli | Isernia | Italy | 86077 |
Sponsors and Collaborators
- Neuromed IRCCS
Investigators
- Principal Investigator: Centonze, IRCSS Neuromed
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Neurology01_2022