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

NCT ID: NCT06873464

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-08-31

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.

Conditions

Multiple Sclerosis, MS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Three cycles of tDCS combined with motor tasks

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Two cycles of tDCS combined with motor tasks

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University of Madrid

OTHER

Sponsor Role: lead

Responsible Party

Marina Castel Sánchez

Marina Castel Sánchez

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundación Esclerosis Multiple Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

CEIm25-10

Identifier Type: -

Identifier Source: org_study_id