Psychometric Evaluation in Patients Wit… | Clinical Trial

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Epilepsy Immune System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Stroke Synucleinopathies Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ircss Neuromed

Pozzilli, Isernia, 86077, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Jul 8, 2022
Registry last updated: Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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