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

NCT ID: NCT06110936

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-03-30

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.

Conditions

Multiple Sclerosis; Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ts-DCS Group

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.

Group Type: EXPERIMENTAL

Transcutaneous Spinal Direct Current Stimulation

Intervention Type: DEVICE

Transcutaneous spinal direct current stimulation (ts-DCS), a neuromodulation technique, is one of the non-invasive brain stimulation techniques. ts-DCS occurs when a continuous and low-intensity electric current passes through electrodes with moist sponges placed on the spinal cord.

Control Group

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.

Group Type: SHAM_COMPARATOR

Transcutaneous Spinal Direct Current Stimulation

Intervention Type: DEVICE

Transcutaneous spinal direct current stimulation (ts-DCS), a neuromodulation technique, is one of the non-invasive brain stimulation techniques. ts-DCS occurs when a continuous and low-intensity electric current passes through electrodes with moist sponges placed on the spinal cord.

Interventions

Transcutaneous Spinal Direct Current Stimulation

Transcutaneous spinal direct current stimulation (ts-DCS), a neuromodulation technique, is one of the non-invasive brain stimulation techniques. ts-DCS occurs when a continuous and low-intensity electric current passes through electrodes with moist sponges placed on the spinal cord.

Intervention Type: DEVICE

Other Intervention Names

transvertebral direct current stimulation

Eligibility Criteria

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

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

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Gulser CINBAZ

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cadde Tıp Merkezi

Istanbul, Kadıköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2021.733

Identifier Type: -

Identifier Source: org_study_id