- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06121635
The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis
February 3, 2024 updated by: Gulser CINBAZ, Istanbul Medeniyet University
The Effects of Transcranial Direct Current Stimulation and Transcutaneous Spinal Direct Current Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis
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.
Study Overview
Status
Active, not recruiting
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gülser Cinbaz
- Phone Number: +905558502576
- Email: gulser.cinbaz@gmail.com
Study Locations
-
-
Kadıköy
-
Istanbul, Kadıköy, Turkey, 34744
- Cadde Tıp Merkezi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Experimental: 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.
|
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.
Other Names:
|
Sham Comparator: 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.
|
Sham ts-DCS and sham t-DCS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed 25-Foot Walk (T25-FW)
Time Frame: 4 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity Scale (FSS)
Time Frame: 4 weeks
|
The scale, which includes the experience of fatigue, its causes and its effects on daily life, consists of 9 questions and is a Likert-type scale where each question takes a value between 0 and 7.
The highest score reached is 63.
A score of 36 or above indicates a high perception of fatigue severity.
|
4 weeks
|
Fatigue Impact Scale (FIS)
Time Frame: 4 weeks
|
FIS will be used to evaluate the reflection of fatigue on daily activities in patients.
This scale evaluates the physical, cognitive and social effects of fatigue in the last month with a total of 40 questions (0 = no problem, 4 = extreme).
The total score ranges from 0-160, with higher scores indicating a higher degree of fatigue impact
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2022
Primary Completion (Actual)
September 20, 2023
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
November 7, 2023
First Posted (Actual)
November 8, 2023
Study Record Updates
Last Update Posted (Actual)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 3, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2020.1075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
Clinical Trials on Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation
-
University of CincinnatiLindner Center of HOPE; Brain & Behavior Research FoundationCompletedMajor Depressive DisorderUnited States
-
Universidade Federal de PernambucoActive, not recruitingAtaxia, CerebellarBrazil
-
Bronx VA Medical CenterNew York State Department of HealthCompletedSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Tetraplegia/TetraparesisUnited States
-
Lebanese American UniversityUnknown
-
Federal University of ParaíbaCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
University of CincinnatiRecruitingPost-stroke DepressionUnited States
-
Shirley Ryan AbilityLabNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Nonfluent AphasiaUnited States
-
Dina Hatem ElhammadyUnknown