Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Multiple Sclerosis, MS
Keywords: Transcranial Direct-Current Stimulation
fatigue
multiple sclerosis
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Fatigue Impact
timeFrame: Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3).
Secondary outcomes:
measure: Multiple Sclerosis Quality of Life assessment
timeFrame: Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3)
measure: Balance
timeFrame: 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)).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Esclerosis Multiple Madrid
Study officials:
References: