Sham tDCS, tDCS
Conditions
Keywords
tdcs, gait, multiple sclerosis, gait training
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.
Interventions
DEVICEtDCS
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.
DEVICEshamtDCS
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.
Sponsors
Asociación Esclerosis Múltiple de Toledo, España
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TUG | 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. |
| Timed 25-Foot Walk | 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
| Measure | Time frame | Description |
|---|---|---|
| MSWS-12 | 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. |
| FSS | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 hours after the stimulation | Questionnaire for adverse events |
| Borg | 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). |
Countries
Spain
Contacts
Primary ContactDiego Serrano Muñoz, PhD
Outcome results
None listed