Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Fatigue, Home-Based exercise, tDCS, Transcranial Direct Current Stimulation
Brief 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.
Detailed description
This study is a randomized, double-blind, controlled clinical trial designed to investigate the efficacy of a combined intervention consisting of a structured home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the treatment of fatigue in patients with multiple sclerosis (MS). Eligible participants will be randomly assigned to one of two parallel groups: An intervention group receiving a prescribed home-based exercise program in combination with active tDCS. A control group receiving the same exercise program combined with sham (placebo) tDCS. The tDCS intervention will target the dorsolateral prefrontal cortex (DLPFC) using a standardized electrode placement, with stimulation parameters based on protocols previously demonstrated to be safe and potentially effective in neurological populations. The sham condition will simulate the sensation of stimulation without delivering an active current, ensuring the integrity of the blinding process for both participants and evaluators. The therapeutic exercise program will focus on improving muscular strength, cardiovascular endurance, balance, and functional mobility, components known to be affected in individuals with MS. The program will be tailored to individual baseline capabilities and progressively adapted throughout the intervention period to optimize participant engagement and safety. Primary outcome measures include changes in functional exercise capacity, as assessed by the Six-Minute Walk Test (6MWT), and fatigue severity, evaluated using the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Adherence to the intervention and tolerability will also be monitored. The proposed study addresses a critical need for accessible, non-pharmacological interventions to manage fatigue, one of the most common and disabling symptoms in MS. By combining physical rehabilitation strategies with neuromodulation techniques, the trial aims to determine whether synergistic effects can be achieved, potentially informing future clinical practices aimed at enhancing the quality of life of individuals with multiple sclerosis.
Interventions
BEHAVIORALHome-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.
DEVICETranscranial 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.
DEVICESham 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.
Sponsors
Jacobo Formigo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blind, parallel assignment trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Capacity Measured by the Six-Minute Walk Test (6MWT) | Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline | The Six-Minute Walk Test (6MWT) will be used to assess participants' functional exercise capacity by recording the total distance walked in six minutes. This test reflects submaximal functional endurance and mobility. Changes in distance walked will be compared to baseline measurements to evaluate improvements. |
Countries
Spain
Contacts
STUDY_DIRECTORJacobo Formigo, Dr,
Complexo Hospitalario Universitario de A Coruña
Outcome results
None listed