NCT03594357

Brief Summary

Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS. The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

July 9, 2018

Last Update Submit

January 29, 2019

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisBalanceCognitionFunctional exercise capacityFatigueSleep quality

Outcome Measures

Primary Outcomes (1)

  • cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests will be used. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) consists of the selective reminding, 10/36 spatial recall, symbol digit modalities, paced auditory serial addition (PASAT) and word list generation tests.

    baseline

Secondary Outcomes (5)

  • Balance

    baseline

  • Functional exercise capacity.

    baseline

  • Fatigue

    baseline

  • Mood

    baseline

  • Sleep Quality

    baseline

Study Arms (2)

Multiple sclerosis

MS patients (EDSS: 0-5,5)

Control

Healthy individuals without chronic disease

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.

You may qualify if:

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

You may not qualify if:

  • Participants who have orthopedic, vision, hearing, or perception problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.

    PMID: 2027484BACKGROUND

  • Rao SM, Grafman J, DiGuilio D, et al. Memory dysfunction in multiple sclerosis: its relation toworking memory, semantic encoding and implicit learning.Neuropsychology 1993; 7:364-374

    BACKGROUND

  • Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.

    PMID: 16643953BACKGROUND

  • Lynch SG, Parmenter BA, Denney DR. The association between cognitive impairment and physical disability in multiple sclerosis. Mult Scler. 2005 Aug;11(4):469-76. doi: 10.1191/1352458505ms1182oa.

    PMID: 16042232BACKGROUND

  • Sandroff BM, Pilutti LA, Benedict RH, Motl RW. Association between physical fitness and cognitive function in multiple sclerosis: does disability status matter? Neurorehabil Neural Repair. 2015 Mar-Apr;29(3):214-23. doi: 10.1177/1545968314541331. Epub 2014 Jul 8.

    PMID: 25009224BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Cagla Ozkul

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 20, 2018

Study Start

September 3, 2018

Primary Completion

December 21, 2018

Study Completion

December 24, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)