Follow-up of Persons With Multiple Sclerosis

NCT03878836 | Unknown

• 1 other identifier: 2959-GOA
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic, progressive and demyelinating disease that affects more than 2.5 million people in the world and is frequently seen in young adults between 20 and 40 years of age, especially in women. Although the exact MS in Turkey is not known, it is estimated as 40/100,000. According to epidemiological studies in recent years, the prevalence and incidence of MS tend to increase. The most common clinical signs and symptoms include loss of sensation in the extremities, partial or total vision loss, acute or subacute motor dysfunction, cognitive impairment, double vision and gait dysfunction. Currently, MS has no definitive cure. Progressive symptoms related to the disease need to be managed in order to increase and maintain the quality of life of individuals with MS. Pharmacological, physiotherapeutic and psychotherapeutic methods are the most effective effective methods in the management of symptoms. However, the efficacy of these methods has been demonstrated in clinical trials. The outcomes cannot be generalized to the entire MS population because of the inclusion and exclusion criteria that exist in clinical trials. In addition, clinical trials are conducted at a specified time interval (usually a short time interval is selected) and generally, short-term results are provided. In order to better understanding the course of MS, it is of utmost importance that long-term follow-up studies are carried out where as many patients are included and patients are followed from the date of initial diagnosis. The aim of this study is to investigate the change of physical, psychosocial and cognitive characteristics over time and the correlated variables. The volunteers from MS patients who attend routine control of the MS outpatient clinic of Dokuz Eylül University Hospital will participate in the study. Physical and clinical assessments will be performed by physicians and physiotherapists, and cognitive evaluations will be performed by psychologists with 6-month intervals.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Expanded Disability Status Scale

  The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

Secondary Outcomes (17)

• Timed 25-Foot Walk

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

• Timed Up and Go test

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

• Single Leg Stance Test

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

• 6-Minute Walk Test

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

• 12-Item Multiple sclerosis walking scale

  Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months

Interventions

Routine assessments OTHER

Routine assessments, no specific intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with multiple sclerosis

You may qualify if:

• Diagnosis of multiple sclerosis
• Willingness to participate

You may not qualify if:

• Severe cognitive, physical, or psychiatric disability that prevent the assessments

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, 35430, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Serkan Ozakbas, MD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan Ozakbas, MD

CONTACT

+902324124064; serkan.ozakbas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 18, 2019
• Study Start: October 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

TU (1)