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 (tDCS)

March 6, 2025 updated by: Marina Castel Sánchez, European University of Madrid

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Fundación Esclerosis Multiple Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Three cycles of tDCS combined with motor tasks group

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
Other: 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.
Active Comparator: Two cycles of tDCS combined with motor tasks group

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:

  • Intensity: 2000 mA
  • Time: 20 minutes with a 10-second ramp-up
  • Electrode Placement: Anode at C3, Cathode at FP2
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3)
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.
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)).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University of Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIm25-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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