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Enrolling by Invitation

NCT Number: NCT06873464

Evaluation of the Efficacy of Transcranial Direct Current Stimulation in Reducing Fatigue and Improving Quality of Life in Patients With Multiple Sclerosis: A Randomized Clinical Trial

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:

* Is the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) more effective for the recovery of fatigue in adult patients with multiple sclerosis compared to the application of two cycles of the same treatment (control group)? * Is tDCS combined with motor therapy effective in improving fatigue in adult patients with multiple sclerosis in both study arms, i.e., in the pre-post assessment of the experimental group and the pre-post assessment of the control group? Researchers will compare the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) to the application of two cycles of the same treatment (control group) to see if the experimental group shows greater recovery of fatigue in adult patients with multiple sclerosis.

Participants will:

* Visit the clinic for two weeks to be evaluated (baseline measurement and first post-treatment assessment) and receive the first cycle of treatment from Monday to Friday. * Have a washout period of one month between the first and the second cycle. * Visit the clinic for two weeks to receive the second cycle of treatment and be evaluated (second post-treatment assessment). * Only participants in the experimental group will have another washout period of one month and visit the clinic to receive a third cycle of treatment and to be evaluated (third post-treatment assessment). * Only participants in the control group will visit the clinic one and a half months after completing their second cycle to be measured as a follow-up.

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Key information

Conditions

Multiple Sclerosis, MS Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Esclerosis Multiple Madrid

Madrid, 28029, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with multiple sclerosis defined according to the McDonald criteria (2017 revised version).
  • Age between 18 and 75 years.
  • No relapse in the last 2 months.
  • Fatigue experienced in the last 6 months, according to the Fatigue Severity Scale (FSS > 4).

Exclusion criteria

  • Patients who have not had stable pharmacological treatment in the last month.
  • Patients with contraindications to the use of tDCS, such as: defibrillator, pacemaker, brain stimulator, implanted intracranial metals, skull fractures or fissures, damaged skin or recent scars, epilepsy, pregnancy.
  • Patients who are undergoing or need to undergo immunosuppressive treatment for MS with Ocrelizumab, Rituximab, Lemtrada, or Mavenclad one week before or during the application of tDCS.
  • Patients with cognitive difficulties that prevent them from understanding the applied scales.
  • Patients who experience adverse effects from tDCS treatment.
  • Inability to remain in the study and complete the third cycle and/or the V3 assessment.

Treatment and study plan

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.

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.

Primary outcomes

  1. Fatigue Impact

    Time frame: Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3).

    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

Secondary outcomes

  1. Multiple Sclerosis Quality of Life assessment

    Time frame: Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3)

    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

  2. Balance

    Time frame: 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)).

    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.

Sponsors and collaborators

Lead sponsor

European University of Madrid

Other

Registry information

Acronym: tDCS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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