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Clinical Trial

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

NCT: NCT07567989 · ENROLLING_BY_INVITATION

NCT IDNCT07567989
StatusENROLLING_BY_INVITATION
Start Date2025-01-01
Completion2026-10-01

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.

Frequently Asked Questions

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

Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis is a clinical trial registered under NCT07567989. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT07567989?

The current status of NCT07567989 (Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis) is: ENROLLING_BY_INVITATION.

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

Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis started on 2025-01-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.