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Follow-up of Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03878836
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Serkan Ozakbas, Dokuz Eylul University

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Other: Routine assessments

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Follow-up of Physical, Psychosocial and Cognitive Influences in Persons With Multiple Sclerosis: a Prospective Cohort Study
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Routine assessments
    Routine assessments, no specific intervention


Primary Outcome Measures :
  1. Expanded Disability Status Scale [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    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.


Secondary Outcome Measures :
  1. Timed 25-Foot Walk [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average of the two completed trials. Higher time represents slower walking speed and more walking impairment.

  2. Timed Up and Go test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.

  3. Single Leg Stance Test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    Single Leg Stance Test measures static balance while standing on a single leg with eyes open and closed. The patient is instructed to remain his/her stability during 60 seconds. The time is recorded while the patient loses his/her stability. The higher time represents better static balance.

  4. 6-Minute Walk Test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.

  5. 12-Item Multiple sclerosis walking scale [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.

  6. Modified Fatigue Impact Scale [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with a Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. Higher score indicates higher level of fatigue.

  7. Epworth Sleepiness Scale [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.

  8. Symbol Digit Modalities Test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Symbol Digit Modalities Test is used to assess mental processing speed. Higher scores indicate better mental processing speed.

  9. California Verbal Learning Test-II [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory.

  10. Revised Brief Visuospatial Memory Test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory.

  11. Godin Leisure Time Exercise Questionnaire [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Godin Leisure Time Exercise Questionnaire is a commonly used questionnaire to measure of usual physical activity in persons with multiple sclerosis. It contains three items that measure the frequency of strenuous, moderate, and mild physical activities for periods of more than 15 minutes during one's free time within a typical week. Weekly frequencies of strenuous, moderate and mild physical activity were multiplied by 9, 5 and 3 metabolic equivalents, respectively, and were summed to form a measure of the total leisure physical activity. Scores range from 0 to 864 (hypothetically). Higher scores indicate higher level of physical activity. Participants with 24 units or more are considired as active, 14 - 23 units as Moderately Active, and Less than 14 units as Insufficiently Active/Sedentary.

  12. Multiple Sclerosis International Quality of Life questionnaire [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Multiple Sclerosis International Quality of Life questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.

  13. Beck Depression Inventory [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Beck Depression Inventory is a widely used 21-items self-reported measure that assesses the presence and intensity of depressive symptoms reflecting the similar symptoms. Each question has a set of at least four possible answer choices, ranging in intensity. Higher scores indicate higher depressive symptoms. The scores range from 0 to 63.

  14. Nine-Hole Peg Test [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.

  15. Nordic Musculoskeletal Questionnaire [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The Nordic Musculoskeletal Questionnaire includes 27 items exploring the presence of musculoskeletal symptoms during a 12-month period covering the nine different parts of the body. It also has items pertaining to severity grades, determined according to functional status and the presence of musculoskeletal symptoms during the last 7 days. All answers are given according to a dichotomous 'yes/no' response.

  16. painDETECT Questionnaire [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The painDETECT Questionnaire is used to detect neuropathic pain components.The questionnaire consists of seven questions that address the quality of neuropathic pain symptoms; it is completed by the patient and no physical examination is required. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of <=12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of >= 19 suggests that pain is likely to have a neuropathic component (> 90%).

  17. International Restless Legs Syndrome Study Group rating scale for restless legs syndrome [ Time Frame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months ]
    The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items. Higher scores indicate higher severity. The scores range from 0 to 40.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with multiple sclerosis
Criteria

Inclusion Criteria:

  • Diagnosis of multiple sclerosis
  • Willingness to participate

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878836


Contacts
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Contact: Serkan Ozakbas, MD +902324124064 ext 4064 serkan.ozakbas@gmail.com

Locations
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Turkey
Dokuz Eylul University Hospital, MS Outpatient Clinic Recruiting
Izmir, Turkey, 35430
Contact: Serkan Ozakbas, MD    +902324124064 ext 4064    serkan.ozakbas@gmail.com   
Sub-Investigator: Turhan Kahraman, PhD         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Principal Investigator: Serkan Ozakbas, MD Dokuz Eylül University

Additional Information:

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Responsible Party: Serkan Ozakbas, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03878836     History of Changes
Other Study ID Numbers: 2959-GOA
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases