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The goal of this clinical trial is to evaluate whether the application of three 2-week cycles of tDCS combined with motor therapy is more effective in reducing fatigue in adult patients with multiple sclerosis, compared to the application of two cycles of the same treatment. The main questions aim to answer:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three cycles of tDCS combined with motor tasks group | Experimental | Three 2-week cycles. Each cycle includes tDCS combined with motor tasks. The initial session of the first cycle and the final sessions of the second and third cycles last 45 minutes, involving tDCS and motor tasks, and MFIS, MSQOL-54, and BBS assessments. Other sessions last 30 minutes, focusing on tDCS and motor tasks. tDCS Parameters: Intensity: 2000 mA Application Time: 20 minutes with a 10-second ramp-up Electrode placement: Anode at C3, Cathode at FP2 |
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| Two cycles of tDCS combined with motor tasks group | Active Comparator | Two 2-week tDCS cycles will be conducted. Each cycle includes tDCS combined with motor tasks. The initial session of the first cycle and the final sessions of the second cycle last 45 minutes, involving tDCS and motor tasks, and MFIS, MSQOL-54, and BBS assessments. Other sessions last 30 minutes, focusing on tDCS and motor tasks. tDCS Parameters:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three cycles of tDCS combined with motor tasks | Other | Three cycles of 2 weeks duration each combining tDCS and motor task. Initial Assessment (V0): Collect demographic data and EDSS, MFIS, MSQOL-54, and BBS results. First Cycle: 2 weeks, Monday to Friday, with a weekend break. Post-First Cycle Assessment (V1): Reassess MFIS, MSQOL-54, and BBS. Washout Period: 1 month without tDCS. Second Cycle: 2 weeks, Monday to Friday, with a weekend break. Final Assessment after Second Cycle (V2): Reassess MFIS, MSQOL-54, and BBS. Washout Period: 1 month. Third Cycle: 2 weeks. Final Assessment after Third Cycle (V3): Reassess MFIS, MSQOL-54, and BBS. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Impact | Fatigue Impact Scale measures the impact of fatigue on daily functioning across three domains: cognitive, physical, and psychosocial. It consists of 40 items rated on a scale from 0 (no problem) to 4 (extreme problem). The total score ranges from 0 to 160, with higher scores indicating greater fatigue impact. Subscale scores are also calculated for each domain | Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3). |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Quality of Life assessment | Multiple Sclerosis Quality of Life - 54 (MSQOL-54) is a multidimensional health-related quality of life measure combining generic and MS-specific items. It includes 54 items generating 12 subscales and two summary scores (physical and mental health). There is no single overall score. Subscale scores and summary scores are derived from a weighted combination of scale scores. Higher scores indicate better quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Esclerosis Multiple Madrid | Madrid | 28029 | Spain |
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| Two cycles of tDCS combined with motor tasks | Other | Initial assessment (V0): Prior to the first tDCS cycle, demographic data and results from the EDSS, MFIS, MSQOL-54, and BBS scales will be collected. First cycle: 2 weeks Post-first cycle assessment (V1): Reassess MFIS, MSQOL-54, and BBS scales. Washout period: 1 month without tDCS treatment. Second cycle: 2 weeks, with sessions from Monday to Friday and a weekend break. Final assessment (V2): After the second cycle, reassess MFIS, MSQOL-54, and BBS scales. Follow-up assessment (V3): 45 days after treatment completion. |
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| Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3) |
| Balance | The Berg Balance Scale assesses static balance and fall risk through 14 tasks, each scored from 0 (lowest function) to 4 (highest function). The total score ranges from 0 to 56. Scores below 45 indicate a higher risk of falling. | Assessed at baseline (V0), post-first cycle (V1, after 2 weeks), post-second cycle (V2, after 6 weeks), and post-third cycle (V3, after 14 weeks)). |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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