Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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