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

Istanbul Medeniyet University

Status: Completed

Conditions: Multiple Sclerosis; Transcranial Direct Current Stimulation

Treatments: Device: Transcutaneous Spinal Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06110936

09.2021.733

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

ts-DCS Group

Experimental group

Description:

ts-DCS will be administered using a direct current stimulator (TCT Research Limited, Hong Kong). 2-mA intensity ts-DCS will be applied to the experimental group, with the active electrode being the cathode electrode. The two electrodes (35-cm2) to be used will be immersed in saline solution (0.9% NaCl). The stimulation electrode (cathodal) will be placed slightly above the spinous process of the T10 vertebral process, while the reference electrode (anodal) will be placed horizontally on the left deltoid.

Treatment:

Device: Transcutaneous Spinal Direct Current Stimulation

Control Group

Sham Comparator group

Description:

ts-DCS will be administered using a direct current stimulator (TCT Research Limited, Hong Kong). 2-mA intensity ts-DCS will be applied to the control group, with the active electrode being the cathode electrode. The two electrodes (35-cm2) to be used will be immersed in saline solution (0.9% NaCl). The stimulation electrode (cathodal) will be placed slightly above the spinous process of the T10 vertebral process, while the reference electrode (anodal) will be placed horizontally on the left deltoid. In the application to the control group, the placement of the electrodes will be the same as the active protocol, and unlike the experimental group, the stimulation will be stopped after 30 seconds. This sham procedure has been reported to be a good pseudostimulation method that does not cause significant experimental effects due to the initial itching sensation it provides.

Treatment:

Device: Transcutaneous Spinal Direct Current Stimulation