Multiple SclerosisNCT06110936
Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis
A study testing Transcutaneous Spinal 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 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. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2023to 30 Mar 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
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.
Read the detailed description
Our study is carried out at Istanbul Cadde Medical Center. The patients who will participate in the study are determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Polyclinic of Istanbul Medeniyet University Göztepe Training and Research Hospital, Department of Neurology. Transcutaneous spinal direct current will be applied to the individuals participating in our study in 20-minute sessions, 3 days a week for 2 weeks. According to the type of stimulation applied, participants are divided into two groups: experimental and control groups by simple randomization. While cathodal ts-DAU was applied to the patients in the experimental group; Sham ts-DAU is applied to patients in the control group. The same evaluations will be applied to all participants throughout the study, and the evaluations are applied 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
- 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 StimulationDevice
Also called transvertebral direct current stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Spinal Direct Current Stimulation |
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: 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.
Measured: 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.
Measured: 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.
Measured: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Fatigue Impact Scale (FIS)
Fatigue Impact Scale 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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start27 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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
- 22 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
- NCT06110936
- Sponsor's protocol ID
- 09.2021.733
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2023
- Last updated
- 18 Apr 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06110936
- Acronym / sponsor ID
- 09.2021.733
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 1 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 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.
Detailed description
Our study is carried out at Istanbul Cadde Medical Center. The patients who will participate in the study are determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Polyclinic of Istanbul Medeniyet University Göztepe Training and Research Hospital, Department of Neurology. Transcutaneous spinal direct current will be applied to the individuals participating in our study in 20-minute sessions, 3 days a week for 2 weeks. According to the type of stimulation applied, participants are divided into two groups: experimental and control groups by simple randomization. While cathodal ts-DAU was applied to the patients in the experimental group; Sham ts-DAU is applied to patients in the control group. The same evaluations will be applied to all participants throughout the study, and the evaluations are applied 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
- 2
| Arm | Type | Receives |
|---|---|---|
| ts-DCS Group | Experimental | Device: Transcutaneous Spinal Direct Current Stimulationts-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. |
| Control Group | Sham comparator | Device: Transcutaneous Spinal Direct Current Stimulationts-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. |
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 StimulationAlso: transvertebral direct current stimulationTranscutaneous 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. | Device | Control Group, ts-DCS Group |
Primary outcome
Timed 25-Foot Walk (T25-FW)
Time frame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
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: It will be evaluated twice:immediately before and immediately after 2 weeks treatment.
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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Fatigue Impact Scale (FIS)
Time frame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
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 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: finished, as of the sponsor's last update on 18 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.). 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 18 Apr 2024.