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)

European University

Status: Invitation-only

Conditions: Multiple Sclerosis, MS

Treatments: Other: Two cycles of tDCS combined with motor tasks; Other: Three cycles of tDCS combined with motor tasks

Study type: Interventional

Funder types: Other

Identifiers

NCT06873464

CEIm25-10

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Three cycles of tDCS combined with motor tasks group

Experimental group

Description:

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

Treatment:

Other: Three cycles of tDCS combined with motor tasks

Two cycles of tDCS combined with motor tasks group

Active Comparator group

Description:

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

Treatment:

Other: Two cycles of tDCS combined with motor tasks