Clinical trial NCT06121635: The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Transcranial Direct Current Stimulation
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timed 25-Foot Walk (T25-FW)
timeFrame: 4 weeks
measure: Time Up and Go (TUG)
timeFrame: 4 weeks
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: 4 weeks
measure: Gait Speed Assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: 4 weeks
measure: Fatigue Impact Scale (FIS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cadde Tıp Merkezi
state: Kadıköy
Study officials:
References: