Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Transcranial Direct Current Stimulation; Multiple Sclerosis

• Registration Number: NCT06110936
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

The primer aim of the study is to examine the effects of the transcutaneous spinal direct current stimulation (ts-DCS) on mobility in addition to the physiotherapy program to individuals with multiple sclerosis. Our secondary aim is to show the relationship of these effects with ts-DCS through fatigue and quality of life evaluations.

Detailed Description

Our study is carried out at Istanbul Cadde Medical Center. The patients who will participate in the study are determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Polyclinic of Istanbul Medeniyet University Göztepe Training and Research Hospital, Department of Neurology. Transcutaneous spinal direct current will be applied to the individuals participating in our study in 20-minute sessions, 3 days a week for 2 weeks. According to the type of stimulation applied, participants are divided into two groups: experimental and control groups by simple randomization. While cathodal ts-DAU was applied to the patients in the experimental group; Sham ts-DAU is applied to patients in the control group. The same evaluations will be applied to all participants throughout the study, and the evaluations are applied before and after the intervention. The data collected as a result of the evaluations will be analyzed with SPSS version 22.

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-01
• Study Start: 2023-11-27
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients diagnosed with MS and suffering from walking difficulties due to MS
• EDSS score between 2-6
• Being over 18 years old

Exclusion Criteria

• Relapsed within the last two months
• Changed medication within 45 days
• Hospitalized in the last three months
• Had other neurological or musculoskeletal problems
• Had an obstacle to stimulation (skin problems, metal implants, etc.)
• Do not want to participate in the study individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time Up and Go (TUG)	It will be evaluated twice: immediately before and immediately after 2 weeks treatment.	It is a performance-based test used to evaluate functional mobility and walking speed. The person is asked to get up from the chair he/she is sitting on without support from his/her arms, walk 3 meters at a safe and normal speed, turn around, walk back, sit on the chair again, and the time is recorded in seconds (sec). The test is started with the patient's feet flat on the floor and arms resting on the armrest of the chair. Three repetitions are made and the best result is recorded.
Gait Speed Assessment	It will be evaluated twice: immediately before and immediately after 2 weeks treatment.	Calculation of walking speed will be done by 2D video analysis method. Kinovea 2D motion analysis software (GPLv2 license, 2019) will be used for analysis. The method has validity and reliability. The videos taken with the cameras placed laterally will be uploaded to the program and the necessary calculations will be made.
Timed 25-Foot Walk (T25-FW)	It will be evaluated twice: immediately before and immediately after 2 weeks treatment.	Timed 25 Foot Walking Test was used for objective evaluation of walking. In T25-FW, which evaluates lower extremity function, the individual is asked to walk 25 steps as quickly and safely as possible (if he/she uses a walking aid, this is done together). The time spent walking is recorded in seconds.
Multiple Sclerosis Walking Scale-12 (MSWS-12)	It will be evaluated twice:immediately before and immediately after 2 weeks treatment.	It is a 12-item rating scale used to assess individuals' perspectives on the impact of their disease on their ability to walk. During the test, patients are asked to rate how much MS affects their mobility, such as standing, walking, running, and climbing stairs, on a 5-point Likert Scale (1=almost not at all, 5=extremely). A high score indicates that walking ability is affected or the patient has difficulty walking. The lowest score can be 12 and the highest score can be 60 from the test.

Secondary Outcome Measures

Name	Time	Method
Fatigue Impact Scale (FIS)	It will be evaluated twice: immediately before and immediately after 2 weeks treatment.	Fatigue Impact Scale will be used to evaluate the reflection of fatigue on daily activities in patients. This scale evaluates the physical, cognitive and social effects of fatigue in the last month with a total of 40 questions (0 = no problem, 4 = extreme). The total score ranges from 0-160, with higher scores indicating a higher degree of fatigue impact
Fatigue Severity Scale (FSS)	It will be evaluated twice: immediately before and immediately after 2 weeks treatment.	The scale, which includes the experience of fatigue, its causes and its effects on daily life, consists of 9 questions and is a Likert-type scale where each question takes a value between 0 and 7. The highest score reached is 63. A score of 36 or above indicates a high perception of fatigue severity.

Trial Locations

Locations (1)

Cadde Tıp Merkezi; 🇹🇷 Istanbul, Kadıköy, Turkey