Clinical trial NCT06110936: Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis
Official title: Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Transcranial Direct Current Stimulation
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 22
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 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.

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: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
measure: Time Up and Go (TUG)
timeFrame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: It will be evaluated twice:immediately before and immediately after 2 weeks treatment.
measure: Gait Speed Assessment
timeFrame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
measure: Fatigue Impact Scale (FIS)
timeFrame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cadde Tıp Merkezi
state: Kadıköy
Study officials:
References: