tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

NCT06986278 | Recruiting

• 1 other identifier: GIFTO-ADEMTO
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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

Keywords

tdcs; gait; multiple sclerosis; gait training

Outcome Measures

Primary Outcomes (2)

• TUG

  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.

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

• Timed 25-Foot Walk

  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.

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

Secondary Outcomes (2)

• MSWS-12

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

• FSS

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

Other Outcomes (2)

• Adverse events

  24 hours after the stimulation

• Borg

  Before stimulation and just immediately after stimulation ends

Study Arms (2)

tDCS

EXPERIMENTAL

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.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

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.

Device: shamtDCS

Interventions

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.

tDCS

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Asociación Esclerosis Múltiple de Toledo, España: collaborator

Study Sites (2)

Asociación de Esclerosis Múltiple de Toledo

Toledo, Toledo, 45071, Spain

RECRUITING

Universidad de Castilla La Mancha

Toledo, Toledo, 45071, Spain

ENROLLING BY INVITATION

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Diego Serrano Muñoz, PhD

CONTACT

+34926051473; diego.serrano@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 22, 2025
• Study Start: May 26, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)