tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

NCT ID: NCT06986278

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

shamtDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Peripheral neurological injury of lower limbs.
• Metal objects in the head.
• Uncontrolled epilepsy.
• Diagnosis of psychiatric disorder.
• Fractures or fissures in the skull.
• Presence of any implanted electronic device (pacemaker, baclofen pump).
• Presence of ulcers in the harness attachment area.
• Osteoporotic fractures in the last 2 years.
• Height > 190 cm.
• Weight > 120 kg.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación Esclerosis Múltiple de Toledo, España

UNKNOWN

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asociación de Esclerosis Múltiple de Toledo

Toledo, Toledo, Spain

Site Status: RECRUITING

Universidad de Castilla La Mancha

Toledo, Toledo, Spain

Site Status: ENROLLING_BY_INVITATION

Countries

Spain

Central Contacts

Diego Serrano Muñoz, PhD

Role: CONTACT

diego.serrano@uclm.es

+34926051473

Facility Contacts

Diego Serrano Muñoz, PhD

Role: primary

diego.serrano@uclm.es

0034 926051473

Other Identifiers

GIFTO-ADEMTO

Identifier Type: -

Identifier Source: org_study_id