Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

This randomized, double-blind, parallel-group clinical trial aims to assess the effectiveness of a combined intervention consisting of a home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the management of fatigue in patients with multiple sclerosis (MS). Fatigue is one of the most disabling and prevalent symptoms in MS, significantly impacting patients' quality of life and functional independence. Participants diagnosed with MS who meet inclusion criteria will be randomized into two groups: Group 1: Home-based therapeutic exercise plus sham (placebo) tDCS Group 2: Home-based therapeutic exercise plus active tDCS The intervention will span a defined period, with tDCS sessions applied over the dorsolateral prefrontal cortex (DLPFC) using a standard montage and parameters validated in previous studies. The sham stimulation group will follow identical procedures without active current delivery, preserving blinding for participants and evaluators. The therapeutic exercise program is designed to be feasible for home implementation, targeting key domains affected in MS such as strength, endurance, balance, and mobility. Exercises will be prescribed based on individual patient assessments and progressively adjusted throughout the intervention period. Primary outcome measures will include functional capacity, evaluated through the Six-Minute Walk Test (6MWT), and fatigue levels, assessed via the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Secondary observations may include adherence rates to the exercise program and subjective reports of tolerability and perceived benefits. This trial seeks to explore whether combining a physical intervention (exercise) with a neuromodulation technique (tDCS) can offer additive benefits in managing fatigue, beyond what exercise alone provides. The ultimate goal is to develop accessible, non-pharmacological treatment strategies to improve daily functioning and quality of life for individuals living with multiple sclerosis.

Key facts

Study ID

NCT07567989

Run by

Jacobo Formigo

People needed

60

Starts

2025-01-01

Expected to finish

2026-10-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent
• Confirmed diagnosis of multiple sclerosis
• Presence of fatigue associated with multiple sclerosis, defined as a fatigue Visual Analogue Scale (VAS) score equal to or greater than 4
• Functional capacity sufficient to perform the Six-Minute Walk Test (6MWT), assessed by a Functional Ambulation Category (FAC) score of 3 or higher

You may not qualify if…

• Presence of any neurological, rheumatological, or other medical condition prior to the diagnosis of multiple sclerosis that could interfere with the study outcomes
• Presence of contraindications for transcranial direct current stimulation (tDCS), such as having a pacemaker, a history of epillepsy, pregnancy, implanted intracranial electrodes, defibrillator, or similar electronic devices.
• Cognitive impairment that limits the participant's ability to collaborate with study procedures.
• Any changes in physical therapy or pharmacological treatments for multiple sclerosis and/or fatigue that are not specified by the study protocol.
• Occurrence of a multiple sclerosis relapse or disease progression with functional repercussions during the study period.

Where it is running

• Complexo Hospitalario Universitario de A Coruña — A Coruña, A Coruña, Spain
• Complexo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain
• Complexo Hospitalario Universitario de Vigo — Vigo, Pontevedra, Spain

Full record on ClinicalTrials.gov

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