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

NCT06110936 | Completed

• 1 other identifier: 09.2021.733
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (4)

• Timed 25-Foot Walk (T25-FW)

  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.

  It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

• Time Up and Go (TUG)

  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.

  It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

• Multiple Sclerosis Walking Scale-12 (MSWS-12)

  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.

  It will be evaluated twice:immediately before and immediately after 2 weeks treatment.

• Gait Speed Assessment

  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.

  It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

Secondary Outcomes (2)

• Fatigue Severity Scale (FSS)

  It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

• Fatigue Impact Scale (FIS)

  It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

Study Arms (2)

ts-DCS Group

EXPERIMENTAL

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.

Device: Transcutaneous Spinal Direct Current Stimulation

Control Group

SHAM COMPARATOR

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.

Device: Transcutaneous Spinal Direct Current Stimulation

Interventions

Transcutaneous Spinal Direct Current Stimulation 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.

Also known as: transvertebral direct current stimulation

Control Group; ts-DCS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Cadde Tıp Merkezi

Istanbul, Kadıköy, 34744, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: November 27, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)