Using brain stimulation with treadmill training to improve walking in multiple sclerosis patients
Transcranial Direct Current Stimulation Combined With Treadmill Training With Partial Body Weight Support in Patients With Multiple Sclerosis
This study is testing if combining brain stimulation with treadmill training can help people with multiple sclerosis walk better and improve their balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Castilla-La Mancha Academic / other |
| Locations | 2 sites (Toledo, Toledo and 1 other locations) |
| Trial ID | NCT06986278 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of transcranial direct current stimulation (tDCS) combined with gait training in patients with multiple sclerosis (MS). It employs a randomized, triple-blind, controlled design to compare the effects of active tDCS against a sham stimulation group, both undergoing the same gait training protocol. The study aims to enhance balance and walking ability, which are often compromised in MS patients, by measuring functional and clinical outcomes related to mobility, balance, and fatigue. The approach builds on previous evidence suggesting that tDCS may positively impact MS symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with multiple sclerosis who have a stable condition and an Expanded Disability Status Scale (EDSS) score between 1 and 6.
Not a fit: Patients with peripheral neurological injuries, uncontrolled epilepsy, or certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve walking ability and balance in patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown positive effects of tDCS in multiple sclerosis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toledo, Toledo and 1 other locations
- Asociación de Esclerosis Múltiple de Toledo — Toledo, Toledo, Spain (Recruiting)
- Universidad de Castilla La Mancha — Toledo, Toledo, Spain (Enrolling_by_invitation)
Study contacts
- Study coordinator: Diego Serrano Muñoz, PhD
- Email: diego.serrano@uclm.es
- Phone: +34926051473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.