Effectiveness of Home-Based Exercise and Brain Stimulation for Reducin
Effectiveness of a Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation (tDCS) as a Treatment for Fatigue in Patients With Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Home-Based Therapeutic Exercise Program
- Transcranial Direct Current Stimulation
Placebo
- Sham tDCS
What it measured
Main measures
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
FatigueChange 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
Other measures (1)
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
Walking and mobilityPhysical function
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Linnhoff S, Haghikia A, Zaehle T. Effects of repetitive twice-weekly transcranial direct current stimulations on fatigue and fatigability in people with multiple sclerosis. Sci Rep. 2023 Apr 11;13(1):5878. doi: 10.1038/s41598-023-32779-y.Background
Mortezanejad M, Ehsani F, Masoudian N, Zoghi M, Jaberzadeh S. Comparing the effects of multi-session anodal trans-cranial direct current stimulation of primary motor and dorsolateral prefrontal cortices on fatigue and quality of life in patients with multiple sclerosis: a double-blind, randomized, sham-controlled trial. Clin Rehabil. 2020 Aug;34(8):1103-1111. doi: 10.1177/0269215520921506. Epub 20Background
Bertoli M, Tataranni A, Porziani S, Pasqualetti P, Gianni E, Grifoni J, L'Abbate T, Armonaite K, Conti L, Cancelli A, Cottone C, Marinozzi F, Bini F, Cecconi F, Tecchio F. Effects on Corticospinal Tract Homology of Faremus Personalized Neuromodulation Relieving Fatigue in Multiple Sclerosis: A Proof-of-Concept Study. Brain Sci. 2023 Mar 29;13(4):574. doi: 10.3390/brainsci13040574.Background
Xian C, Barbi C, Goldsworthy MR, Venturelli M, Sidhu SK. The interaction between metaplastic neuromodulation and fatigue in multiple sclerosis. J Neurol Sci. 2023 Jan 15;444:120521. doi: 10.1016/j.jns.2022.120521. Epub 2022 Dec 11.
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History
Started
Jan 2025
Main results due
Aug 2026
Finished
Oct 2026