Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06986278

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

Led by University of Castilla-La Mancha · Updated on 2025-05-29

78

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

Sponsors

U

University of Castilla-La Mancha

Lead Sponsor

A

Asociación Esclerosis Múltiple de Toledo, España

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the therapeutic effects of transcranial direct current stimulation (tDCS), a non-invasive method that alters brain activity, combined with gait training in people with multiple sclerosis (MS). The study aims to improve balance and walking ability, which are often affected in MS patients, using a randomized, triple-blind, controlled design comparing active tDCS with sham stimulation alongside identical gait training. This builds on previous evidence suggesting beneficial effects of tDCS in MS and seeks to confirm these findings with an optimized stimulation approach. Participants will receive either active tDCS or sham stimulation using the same device and electrode placement. Active tDCS applies 2 mA current for 20 minutes with electrodes placed on the head and right shoulder, secured with a cap and bandage. The sham group receives a brief, low-level stimulation mimicking the device's sensations without therapeutic current. Both groups will undergo 20-minute treadmill gait training sessions supported by a body-weight support harness to promote motor relearning and ensure safety. During the study, participants will be assessed before treatment, after the 10th session, and at a 4-week follow-up. Researchers will measure walking speed and balance using tests like the Timed Up and Go (TUG) and Timed 25-Foot Walk, along with questionnaires on walking ability and fatigue. Safety and clinical outcomes will be monitored throughout, with the total participation duration spanning the intervention and follow-up periods.

CONDITIONS

Brief Title

tdCS Combined With Treadmill Training in Patients With Multiple Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 greater than 190 cm
  • Weight greater than 120 kg

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 sessions

Participants receive transcranial direct current stimulation combined with treadmill training using a body-weight support system. Each session lasts 20 minutes to promote motor relearning.

10 visits (in-person)

Follow-up

Duration - 4 weeks

Participants are assessed 4 weeks after completing the treatment to evaluate lasting effects.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

Asociación de Esclerosis Múltiple de Toledo

Toledo, Toledo, Spain, 45071

Actively Recruiting

2

Universidad de Castilla La Mancha

Toledo, Toledo, Spain, 45071

Enrolling by Invitation

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Research Team

D

Diego Serrano Muñoz, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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