NCT06986278

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• tDCS
• Sham tDCS

Interventions

Type	Name	Description
DEVICE	tDCS	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.
DEVICE	shamtDCS	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.

Timeline

• Start date: 2025-05-26
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2025-05-22
• Last updated: 2025-05-29

Locations

2 sites across 1 country: Spain