Cognitive Function in Multiple Sclerosis

NCT06084182 | Completed

• 1 other identifier: 2021/2611
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; cognitive function; cognitive reserve; functional capacity

Outcome Measures

Primary Outcomes (5)

• Functional capacity assessment

  6-minute walk test were used. The 6-minute walk test requires patients to cover as much distance as possible in a six-minute period. The walking distance is recorded.

  Baseline

• Functional capacity assessment

  The STS-5 test, on the other hand, requires patients to perform five sit-stand cycles in a standard chair (0.43-m high and 0.45-m wide) as quickly as possible, measured in seconds, and is used as an indicator of lower extremity muscle strength.

  baseline

• Cognitive function

  A mobile application called Trail Making Test was used to evaluate visual attention and cognitive flexibility. The completion time of subsections A and B was recorded. Working memory will be evaluated using a mobile application called Digit Span test. This application gives your maximum digit memory. This score has been saved.

  Baseline

• Visiospatial perception

  The visuospatial perception was evaluated with the help of the mobile application called Corsi Block Tapping test. The highest span in this application is recorded.

  Baseline

• Cognitive Reserve Index Questionnaire

  A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve".

  Baseline

Secondary Outcomes (5)

• Hand grip strength

  Baseline

• Nottingham Health Profile.

  Baseline

• Beck Depression Inventory

  Baseline

• Fatigue Severity Scale.

  Baseline

• Reaction time

  Baseline

Study Arms (2)

Patient group

OTHER

Patients with a definite diagnosis of MS according to McDonald diagnostic criteria

Other: Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment

Control Group

NO INTERVENTION

Healthy individuals

Interventions

Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment OTHER

6-minute walk test and 5-time sit-to-stand test (STS-5) were used for functional capacity assessment. For cognitive reserve assessment, the Cognitive Reserve Index questionnaire was used. Reaction time, cognitive function and visiospatial perception were evaluated with the mobile application. In addition, the Fatigue Severity Scale; Beck Depression Questionnaire and Nottingham Health Profile were used.

Patient group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsing-remitting MS diagnosis
• Expanded Disability Status Scale score \<5.5
• Being able to use a smart phone
• No relapse during the last 30 days
• Being between the ages of 18-65
• Mini-Mental State Examination score\>24

You may not qualify if:

• Severe Visual Impairment
• Severe Psychiatric Disorder,
• Severe Arthritis in Knee or Hip,
• Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

• Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024 Sep;82(9):1-9. doi: 10.1055/s-0044-1788273. Epub 2024 Aug 26.

  PMID: 39187267 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Reaction Time

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Engin Ramazanoglu

  Inonu University

  STUDY CHAIR

• Mehmet Tecellioglu

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: October 16, 2023
• Study Start: November 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

TU (1)