RecruitingNot ApplicableNCT06986278

tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

Transcranial Direct Current Stimulation Combined With Treadmill Training With Partial Body Weight Support in Patients With Multiple Sclerosis

Sponsor

University of Castilla-La Mancha

Enrollment

78 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

tDCS Sham tDCS

Summary

This clinical trial aims to evaluate the therapeutic effectiveness of transcranial direct current stimulation (tDCS), a non-invasive technique that modulates cortical excitability, in combination with gait training in patients with multiple sclerosis (MS). The study focuses on improving balance and walking ability, which are commonly impaired in this population. A randomized, triple-blind, controlled design will be used, comparing an active tDCS group with a sham stimulation group, both receiving the same gait training protocol. Outcomes will include functional and clinical measures related to mobility, balance, and fatigue. The project builds on previous meta-analytical evidence suggesting positive effects of tDCS in MS and aims to confirm these findings using an optimized stimulation protocol.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining mild electrical brain stimulation (called tDCS) with treadmill walking exercises improves mobility and function in people with multiple sclerosis (MS). **You may be eligible if...** - You have been diagnosed with multiple sclerosis - Your disability level is mild to moderate (EDSS score between 1 and 6) - Your condition has been stable for the last 3 months - You are able to understand and follow instructions **You may NOT be eligible if...** - You have nerve damage in your lower limbs unrelated to MS - You have metal objects in your head - You have uncontrolled epilepsy - You have a diagnosed psychiatric disorder - You have skull fractures or fissures - You have an implanted electronic device (e.g., pacemaker or baclofen pump) - You weigh more than 120 kg or are taller than 190 cm - You have had an osteoporotic fracture in the last 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtDCS

Stimulation will be applied at an intensity of 2 mA for 20 minutes, with an average ramp-up and ramp-down rate of 0.1 mA/s, using rectangular electrodes of 35 cm² (resulting in a current density of 0.06 mA/cm²) covered with sponges moistened with 0.9% saline solution. A Sooma tDCS™ direct current stimulator (Sooma Oy Ltd, Helsinki, Finland), certified for clinical use, will be used. The anode will be placed over the Cz stimulation site, and the cathode will be placed on the right shoulder. The electrode will be secured to the participant's head using a neoprene cap (Neuroelectrics, Barcelona, Spain) and to the shoulder with a crepe bandage.

DEVICEshamtDCS

The sham tDCS group will use the same device and electrode placement as the active stimulation group. The protocol will consist of a 10-second ramp-up to 1 mA, followed by a 7-second ramp-down to 0.3 mA, which will be maintained for 19 minutes and 40 seconds, and a final 3-second ramp-down to 0 mA. This sham stimulation method is integrated into the Sooma stimulator.