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| Name | Class |
|---|---|
| Asociación Esclerosis Múltiple de Toledo, España | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MSWS-12 | 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. | Pre intervention, at the end of 10th session, and follow-up at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Questionnaire for adverse events | 24 hours after the stimulation |
| Borg | "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)." |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Serrano Muñoz, PhD | Contact | +34926051473 | diego.serrano@uclm.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AsociaciĂłn de Esclerosis MĂşltiple de Toledo | Recruiting | Toledo | Toledo | 45071 | Spain |
Scientific Journal
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. |
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| FSS |
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. |
| Pre intervention, at the end of 10th session, and follow-up at 4 weeks |
| Before stimulation and just immediately after stimulation ends |
| Universidad de Castilla La Mancha | Enrolling by invitation | Toledo | Toledo | 45071 | Spain |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |