Multiple SclerosisNCT06121635
The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis
A study testing Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation in people with Multiple Sclerosis and Transcranial Direct Current Stimulation, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Transcranial Direct Current Stimulation
- What is being tested?
- Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with MS and suffering from walking difficulties due to MS
- EDSS score between 2-6
- Being over 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation, Sham ts-DCS and sham t-DCS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current StimulationCombination product
Also called robot-assisted gait training
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.
Sham ts-DCS and sham t-DCSCombination product
Sham ts-DCS and sham t-DCS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: Sham ts-DCS and sham t-DCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
Fatigue Severity Scale (FSS)
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.
Measured: 4 weeks
Fatigue Impact Scale (FIS)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start20 Dec 2023
- Primary completion15 May 2024
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulser CINBAZ, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121635
- Sponsor's protocol ID
- 09.2020.1075
- Status last verified
- May 2024
- First submitted
- 23 Oct 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation and Transcutaneous Spinal Direct Current Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06121635
- Acronym / sponsor ID
- 09.2020.1075
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ts-DCS Group | Experimental | Combination Product: Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current StimulationActive 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. |
| t-DCS Group | Experimental | Combination Product: Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current StimulationActive 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. |
| Control Group | Sham comparator | Combination Product: Sham ts-DCS and sham t-DCSSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with MS and suffering from walking difficulties due to MS
- EDSS score between 2-6
- Being over 18 years old
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current StimulationAlso: robot-assisted gait trainingAt 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. | Combination product | t-DCS Group, ts-DCS Group |
| Sham ts-DCS and sham t-DCSSham ts-DCS and sham t-DCS | Combination product | Control Group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: 4 weeks
Fatigue Impact Scale (FIS)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation in people with Multiple Sclerosis and Transcranial Direct Current Stimulation, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25-Foot Walk (T25-FW) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.