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Clinical Trials in Spain / NCT06873464
Enrolling by invitation Not applicable

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

NCT06873464 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-02-20
Last updated
2025-03-12

Condition(s) studied

Multiple Sclerosis, MS

Investigational drug(s) / intervention(s)

Three cycles of tDCS combined with motor tasksTwo cycles of tDCS combined with motor tasks

Three cycles of tDCS combined with motor tasks: 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: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fundación Esclerosis Multiple Madrid Madrid Spain

More European University of Madrid trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06873464 on ClinicalTrials.gov ↗ ← All trials in Spain