Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation (NeuroPsyc)

October 14, 2024 updated by: Diego Centonze, Neuromed IRCCS
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Isernia
      • Pozzilli, Isernia, Italy, 86077
        • Ircss Neuromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Investigators

  • Principal Investigator: Centonze, Ircss Neuromed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Punto 5 O.d.g. 30.06.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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