tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis (TDCS)

University of Castilla-La Mancha

Status: Enrolling

Conditions: Sham tDCS; tDCS

Treatments: Device: tDCS; Device: shamtDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06986278

GIFTO-ADEMTO

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

tDCS

Experimental group

Description:

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.

Treatment:

Device: tDCS

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: shamtDCS