Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis

Universidad de Almeria38 enrolled

Overview

Multiple sclerosis (MS) is a chronic, inflammatory and disabling disease of the Cnetral Nervous System characterized by relapsing and / or progressive somatosensory, motor and vestibular clinical manifestations. Moreover, fatigue, depression, anxiety, and cognitive impairment are also present in most MS patients. These symptoms substantially impact quality of life and often show limited response to conventional pharmacological treatment. Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner. The objective of this study is to evaluate the efficacy and safety of tDCS for fatigue, depression, anxiety, and cognitive performance in patients with relapsing or progressive MS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis, MS Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

Transcranial Direct Current StimulationDEVICE

Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner. tDCS has an established safety profile across the populations and protocols studied to date. This study uses an anodal stimulation montage of the dorsolateral prefrontal cortex (DLPFC).

Sham transcranial direct current stimulation simulationDEVICE

Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-55 years at the time of enrollment * Clinical diagnosis of Relapsing Multiple Sclerosis (RMS) or Progressive Multiple Sclerosis (PMS), with or without active progression, established per the 2014 McDonald diagnostic criteria * Expanded Disability Status Scale (EDSS) score of 0-3 at the time of screening * Time since initial MS diagnosis of at least 6 months * Active fatigue symptoms reported by the participant for at least the 6 months prior to enrollment Exclusion Criteria: * History of neuropsychiatric illness (including major depression, bipolar disorder, schizophrenia, or any anxiety disorder) prior to the onset of multiple sclerosis * Diagnosis of neuromyelitis optica spectrum disorder (Devic's disease) * Presence of any other central nervous system disease * Disease duration greater than 10 years combined with an EDSS score of ≤ 2 * Visual impairment secondary to optic neuritis, internuclear ophthalmoplegia (oculomotor disorder), or any other uncorrected visual impairment that would affect task performance on cognitive assessments * Current pharmacological treatment for fatigue or depression * Current neuropsychiatric pharmacological treatment, including any antidepressant, anxiolytic, neuroleptic, or anticonvulsant medication * Clinical relapse requiring corticosteroid treatment in the 3 months prior to enrollment * Severe upper-limb motor deficit that would prevent task performance on neuropsychological assessments

Outcomes

Primary Outcomes

Modified Fatigue Impact Scale (MFIS) - Total Score

The MFIS is a 21-item multidimensional self-report scale assessing the impact of fatigue on physical (9 items), cognitive (10 items), and psychosocial (2 items) functioning over the past 4 weeks. Each item is scored 0-4; total score ranges from 0 to 84. Higher scores indicate greater fatigue impact. The primary comparison is post-active-tDCS total score versus post-sham total score.

Time frame: Assessed at baseline (Day 0), immediately following the first 5-day stimulation block (Day 5), and immediately following the second 5-day stimulation block (Day 26 after washout)

Modified Fatigue Impact Scale (MFIS) - Physical Subscale

Physical subscale of the MFIS (9 items; range 0-36). Assesses impact of fatigue on physical functioning. Compared between active tDCS and sham conditions.