Follow-up of Persons With Multiple Sclerosis

NCT ID: NCT03878836

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2021-08-01

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

Study Design

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

Interventions

Routine assessments

Routine assessments, no specific intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple sclerosis
• Willingness to participate

Exclusion Criteria

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

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

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Serkan Ozakbas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serkan Ozakbas, MD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Serkan Ozakbas, MD

Role: CONTACT

serkan.ozakbas@gmail.com

+902324124064 ext. 4064

Facility Contacts

Serkan Ozakbas, MD

Role: primary

serkan.ozakbas@gmail.com

+902324124064 ext. 4064

Other Identifiers

2959-GOA

Identifier Type: -

Identifier Source: org_study_id