Fatigue, Fatigue in Multiple Sclerosis, Multiple Sclerosis, Multiple Sclerosis, MS, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) - Relapsing-remitting, Non-invasive Brain Stimulation, Transcranial Direct Current Stimulation
Conditions
Keywords
Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis, Multiple Sclerosis, Fatigue, transcranial direct current stimulation, mood, cognition, non-invasive brain stimulation
Brief summary
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.
Interventions
DEVICETranscranial Direct Current Stimulation
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).
DEVICESham transcranial direct current stimulation simulation
Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation
Sponsors
Universidad de Almeria
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) - Total Score | 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) | 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. |
| Modified Fatigue Impact Scale (MFIS) - Physical Subscale | Baseline, Day 5, Day 26 | Physical subscale of the MFIS (9 items; range 0-36). Assesses impact of fatigue on physical functioning. Compared between active tDCS and sham conditions. |
| Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale | Baseline, Day 5, Day 26 | Cognitive subscale of the MFIS (10 items; range 0-40). Assesses impact of fatigue on cognitive functioning. Compared between active tDCS and sham conditions. |
| Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale | Baseline, Day 5, Day 26 | Psychosocial subscale of the MFIS (2 items; range 0-8). Assesses impact of fatigue on psychosocial functioning. Compared between active tDCS and sham conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Baseline, Day 5, Day 26 | 7-item subscale of the HADS assessing anxiety symptom severity. Each item is scored 0-3; subscale range 0-21. Higher scores indicate greater anxiety. Compared between active tDCS and sham conditions. |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | Baseline, Day 5, Day 26 | 7-item subscale of the HADS assessing depression symptom severity. Each item is scored 0-3; subscale range 0-21. Higher scores indicate greater depression. Compared between active tDCS and sham conditions. |
| Visual Analog Scale (VAS) - Fatigue | Baseline, Day 5, Day 26 | Participant-rated 0-10 point visual analog scale for subjective fatigue severity (0 = no fatigue, 10 = worst imaginable fatigue). Used as a brief supplementary measure alongside the MFIS. |
| Visual Analog Scale (VAS) - Depression | Baseline, Day 5, Day 26 | Participant-rated 0-10 point visual analog scale for subjective depression severity (0 = no depression, 10 = worst imaginable depression). Used as a brief supplementary measure alongside the HADS. |
| Symbol Digit Modalities Test (SDMT) | Baseline, Day 5, Day 26 | Validated test of information-processing speed and working memory, part of the Brief International Cognitive Assessment for MS (BICAMS). The participant substitutes symbols for digits within 90 seconds; higher scores indicate better performance. Compared between active tDCS and sham conditions. |
| California Verbal Learning Test-II (CVLT-II) | Baseline, Day 5, Day 26 | Standardized measure of short-term verbal learning and memory, part of the BICAMS battery. Assessed as total correct recall across learning trials; higher scores indicate better performance. Compared between active tDCS and sham conditions. |
| Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline, Day 5, Day 26 | Standardized measure of short-term visuospatial memory and learning, part of the BICAMS battery. Assessed as total correct recall across learning trials; higher scores indicate better performance. Compared between active tDCS and sham conditions. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORASDRUBAL R HUERTA GALLANGO, MD / PhD
Universidad de Almeria
PRINCIPAL_INVESTIGATORLuis Fernando Sánchez-Santed, PhD
Universidad de Almeria
Outcome results
None listed