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NCT Number: NCT06986278

tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

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.

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Key information

Conditions

tDCS Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Sham tDCS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación de Esclerosis Múltiple de Toledo, Toledo, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

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.

shamtDCS

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.

Primary outcomes

  1. TUG

    Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks

    Timed Up and Go (TUG) Test: Measures the time it takes for the patient to safely stand up from a chair with armrests, walk three meters to a marked line, turn around, return to the chair, and sit down. The patient may use assistive devices if needed.

  2. Timed 25-Foot Walk

    Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks

    Timed 25-Foot Walk (T25-FW): Assesses gait speed by measuring the time it takes for a patient to walk a distance of 25 feet.

Secondary outcomes

  1. MSWS-12

    Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks

    12-Item Multiple Sclerosis Walking Scale (MSWS-12): A patient-reported outcome measure that assesses self-perceived walking ability by asking about mobility-related aspects over the past 15 days. Values: 12 up to 60. Higher scores mean worse walking ability.

  2. FSS

    Time frame: Pre intervention, at the end of 10th session, and follow-up at 4 weeks

    Fatigue severity scale. The FSS measures the severity of fatigue and its impact on daily functioning. Scores range from 9 to 63, with higher scores reflecting more severe fatigue.

Other outcomes

  1. Adverse events

    Time frame: 24 hours after the stimulation

    Questionnaire for adverse events

  2. Borg

    Time frame: Before stimulation and just immediately after stimulation ends

    "Modified Borg Scale. It measures the perception of effort and the intensity of physical activity on a scale from 0 (complete rest) to 10 (maximum effort)."

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Serrano Muñoz, PhD

CONTACT

[email protected]

+34926051473

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Asociación Esclerosis Múltiple de Toledo, España

Registry information

Official study title

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

Acronym: TDCS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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