Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation

NCT ID: NCT05450237

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-06-01

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.

Conditions

Multiple Sclerosis; Epilepsy; Parkinson Disease; Dementia; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Diego Centonze

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Centonze

Role: PRINCIPAL_INVESTIGATOR

IRCSS Neuromed

Locations

Ircss Neuromed

Pozzilli, Isernia, Italy

Countries

Italy

References

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Other Identifiers

Punto 5 O.d.g. 30.06.2022

Identifier Type: -

Identifier Source: org_study_id