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

Condition(s) studied

Investigational drug(s) / intervention(s)

Home-Based Therapeutic Exercise Program: Participants will engage in a structured home-based therapeutic exercise program administered via a smartphone application. The program consists of targeted strength training, stretching routines, and proprioceptive exercises designed to address functional impairments commonly observed in individuals with multiple sclerosis. Each session will have an approximate duration of 20 to 30 minutes. Participants are required to complete a minimum of three sessions per week for the duration of the intervention phase.

Transcranial Direct Current Stimulation: Transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC). Stimulation will be delivered using a standard electrode montage, with the anode positioned over the left DLPFC and the cathode over the contralateral supraorbital area. The stimulation parameters will include a current intensity of 1.5 mA applied for 20 minutes per session, with a ramp-up and ramp-down phase of 10 seconds each at the beginning and end of stimulation, respectively. Sessions will be conducted five days per week over a two-week period, for a total of 10 sessions.

Sham tDCS: Participants assigned to the sham tDCS condition will receive identical electrode placement to the active tDCS group, with the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the contralateral supraorbital area. The stimulation device will deliver an initial ramp-up phase of 10 seconds of actual stimulation after which no current will be delivered for 1180 seconds, and ending by a ramp-down phase of 10 seconds, The total session duration will match that of the active group (20 minutes), ensuring participant blinding. Sessions will occur five days per week over a two-week period, for a total of 10 sessions.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS) — Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
  Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The primary endpoint is the percentage reduction in the FSS total score compared to baseline. A clinically meaningful improvement is defined as a reduction greater than 20% in the FSS total score (approximately 13 points). Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effects.
• Change in Fatigue Severity Measured by Visual Analogue Scale (VAS) for Fatigue — Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
  Fatigue severity will be assessed using a Visual Analogue Scale (VAS) for fatigue. The primary endpoint is the change in VAS fatigue score compared to baseline. A clinically meaningful improvement is defined as a reduction of at least 2 points on the VAS. Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effect

Trial sites (3)

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