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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to understand and follow instructions.

• Diagnosis of Multiple Sclerosis according to McDonald criteria.

• Expanded Disability Status Scale (EDSS) between 1 and 6.

• Stable condition in the last three months.

Locations
Other Locations
Spain
Asociación de Esclerosis Múltiple de Toledo
RECRUITING
Toledo
Universidad de Castilla La Mancha
ENROLLING_BY_INVITATION
Toledo
Contact Information
Primary
Diego Serrano Muñoz, PhD
diego.serrano@uclm.es
+34926051473
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 78
Treatments
Experimental: 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 circular 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. Gait training will be performed using a treadmill and a body-weight support system consisting of a harness that also serves as a safety mechanism in case of a fall. Each session will last 20 minutes to allow for a sufficient number of gait cycles to promote motor relearning.
Sham_comparator: Sham tDCS
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. Gait training will be performed using a treadmill and a body-weight support system consisting of a harness that also serves as a safety mechanism in case of a fall. Each session will last 20 minutes to allow for a sufficient number of gait cycles to promote motor relearning.
Related Therapeutic Areas
Sponsors
Leads: University of Castilla-La Mancha
Collaborators: Asociación Esclerosis Múltiple de Toledo, España

This content was sourced from clinicaltrials.gov