tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

Official title

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

Overview

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.

Interventions

• 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 e
• 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.

Primary outcome measures

• TUG [Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks]
• Timed 25-Foot Walk [Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks]

Secondary outcome measures (2)

• MSWS-12 [Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks]
• FSS [Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Asociación de Esclerosis Múltiple de Toledo — Toledo
• Universidad de Castilla La Mancha — Toledo

Identifiers

NCT: NCT06986278 · GIFTO-ADEMTO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗