The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis

NCT ID: NCT06121635

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-07-30

Brief Summary

The primary aim of this study is to determine the transcranial direct current stimulation and transcutaneous spinal direct current stimulation in addition to robot-assisted walking training in individuals with Multiple sclerosis; to examine the effects on motor functions against each other and sham application. Secondary aim of this study is to show the relation of these effects with tDCS and ts-DCS through fatigue and quality of life evaluations.

Detailed Description

These study is planned to be carried out in the Cadde Medical Center clinic. The patients who will participate in the study will be determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Outpatient Clinic of Istanbul Medeniyet University Göztepe Research Hospital, Department of Neurology. As a result of the power analysis, 36 participants were planned to be included in the study. 20 minutes of non-invasive brain stimulation will be applied to the individuals participating in these study before the 20 minutes robot-assisted walking training (RATG), 3 days a week for 4 weeks. Participants will be divided into 3 groups according to the type of stimulation applied by simple randomization. These groups are 1) anodal tDCS + sham ts-DCS; 2) sham tDCS + cathodal ts-DCS 3) sham tDCS + sham ts-DCS. The same evaluations will be applied to all participants during the study and the evaluations are planned as 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

Active ts-DCS and sham t-DCS will be applied simultaneously. 2mA intensity ts-DCS will be applied, with the active electrode being the cathode. The cathode will be placed the spinous process of T10 vertebral process, while the anode will be placed on the left deltoid. 2mA intensity t-DCS will be applied, with the active electrode being the anode. The International EEG 10/20 System will be used to electrode placement. The anode will be placed on the left M1, while the catode will be placed on the right supraorbital region. In the sham application, the placement of the electrodes will be the same as the active stimulation but It's will be stopped after 30 seconds. This sham procedure has been reported to be a good pseudostimulation method. ts-DCS and t-DCS will be administered using a stimulator (TCT Research Limited, Hong Kong). In both stimulations, 2 electrodes (35 cm2) immersed in saline solution will be used. The stimulations will be applied in 20 min sessions, 3 days/4 weeks.

Group Type: EXPERIMENTAL

Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation

Intervention Type: COMBINATION_PRODUCT

At the robot-assisted gait training, 20-minute gait training for the patient at an appropriate speed with the Locohelp Woodway device. The aim is to re-teach proper walking, gait cycle timing, and create a near-normal gait pattern through multiple repetitions. Robot-assisted gait training will be performed immediately following the stimulation applied to the patients.

t-DCS Group

Active t-DCS and sham ts-DCS will be applied simultaneously. 2mA intensity t-DCS will be applied, with the active electrode being the anode. The International EEG 10/20 System will be used to electrode placement. The anode will be placed on the left M1, while the catode will be placed on the right supraorbital region. 2mA intensity ts-DCS will be applied, with the active electrode being the cathode. The cathode will be placed the spinous process of T10 vertebral process, while the anode will be placed on the left deltoid. In the sham application, the placement of the electrodes will be the same as the active stimulation but It's will be stopped after 30 seconds. This sham procedure has been reported to be a good pseudostimulation method. ts-DCS and t-DCS will be administered using a stimulator (TCT Research Limited, Hong Kong). In both stimulations, 2 electrodes (35 cm2) immersed in saline solution will be used. The stimulations will be applied in 20 min sessions, 3 days/4 weeks.

Group Type: EXPERIMENTAL

Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation

Intervention Type: COMBINATION_PRODUCT

At the robot-assisted gait training, 20-minute gait training for the patient at an appropriate speed with the Locohelp Woodway device. The aim is to re-teach proper walking, gait cycle timing, and create a near-normal gait pattern through multiple repetitions. Robot-assisted gait training will be performed immediately following the stimulation applied to the patients.

Control Group

Sham ts-DCS and sham t-DCS will be applied simultaneously. 2mA intensity ts-DCS will be applied, with the active electrode being the cathode. The cathode will be placed the spinous process of T10 vertebral process, while the anode will be placed on the left deltoid. 2mA intensity t-DCS will be applied, with the active electrode being the anode. The International EEG 10/20 System will be used to electrode placement. The anode will be placed on the left M1, while the catode will be placed on the right supraorbital region. In both stimulations, the placement of the electrodes in Sham application will be the same as in active stimulation, but it will be stopped after 30 seconds. ts-DCS and t-DCS will be administered using a stimulator (TCT Research Limited, Hong Kong). In both stimulations, 2 electrodes (35 cm2) immersed in saline solution will be used. The stimulations will be applied in 20 min sessions, 3 days/4 weeks.

Group Type: SHAM_COMPARATOR

Sham ts-DCS and sham t-DCS

Intervention Type: COMBINATION_PRODUCT

Sham ts-DCS and sham t-DCS

Interventions

Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation

At the robot-assisted gait training, 20-minute gait training for the patient at an appropriate speed with the Locohelp Woodway device. The aim is to re-teach proper walking, gait cycle timing, and create a near-normal gait pattern through multiple repetitions. Robot-assisted gait training will be performed immediately following the stimulation applied to the patients.

Intervention Type: COMBINATION_PRODUCT

Sham ts-DCS and sham t-DCS

Sham ts-DCS and sham t-DCS

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

robot-assisted gait training

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

09.2020.1075

Identifier Type: -

Identifier Source: org_study_id