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

NCT06121635 | Active Not Recruiting

• 1 other identifier: 09.2020.1075
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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.

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (2)

• Fatigue Severity Scale (FSS)

  4 weeks

• Fatigue Impact Scale (FIS)

  4 weeks

Study Arms (3)

ts-DCS Group

EXPERIMENTAL

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.

Combination Product: Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation

t-DCS Group

EXPERIMENTAL

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.

Combination Product: Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation

Control Group

SHAM COMPARATOR

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.

Combination Product: Sham ts-DCS and sham t-DCS

Interventions

Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation 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.

Also known as: robot-assisted gait training

t-DCS Group; ts-DCS Group

Sham ts-DCS and sham t-DCS COMBINATION_PRODUCT

Sham ts-DCS and sham t-DCS

Control 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

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not be informed whether the stimulations applied are active or sham.
• 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 8, 2023
• Study Start: December 20, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 30, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)