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 | Enrolling By Invitation

• 1 other identifier: CEIm25-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Transcranial Direct-Current Stimulation; fatigue; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Fatigue Impact

  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 Outcomes (2)

• Multiple Sclerosis Quality of Life assessment

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

• Balance

  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)).

Study Arms (2)

Three cycles of tDCS combined with motor tasks group

EXPERIMENTAL

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

Two cycles of tDCS combined with motor tasks group

ACTIVE COMPARATOR

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

Interventions

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.

Three cycles of tDCS combined with motor tasks group

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.

Two cycles of tDCS combined with motor tasks group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

Fundación Esclerosis Multiple Madrid

Madrid, 28029, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marina Castel Sánchez

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 12, 2025
• Study Start: February 20, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

ES (1)