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Completed

NCT Number: NCT07680738

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

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.

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Key information

Conditions

Multiple Sclerosis, MS Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Fatigue Fatigue in Multiple Sclerosis Immune System Diseases Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis (MS) Primary Progressive Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Non-invasive Brain Stimulation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Transcranial Direct Current Stimulation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurociencia Clínica Integral

Mexico City, 11580, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 simulation

Device

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

Primary outcomes

  1. Modified Fatigue Impact Scale (MFIS) - 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)

    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.

  2. Modified Fatigue Impact Scale (MFIS) - Physical Subscale

    Time frame: 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.

  3. Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale

    Time frame: 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.

  4. Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale

    Time frame: 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 outcomes

  1. Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

    Time frame: 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.

  2. Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

    Time frame: 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.

  3. Visual Analog Scale (VAS) - Fatigue

    Time frame: 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.

  4. Visual Analog Scale (VAS) - Depression

    Time frame: 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.

  5. Symbol Digit Modalities Test (SDMT)

    Time frame: 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.

  6. California Verbal Learning Test-II (CVLT-II)

    Time frame: 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.

  7. Brief Visuospatial Memory Test-Revised (BVMT-R)

    Time frame: 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.

Other outcomes

  1. Adverse events - frequency and type

    Time frame: After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)

    Adverse events assessed by structured interview after each stimulation session, including tingling, stinging, burning, headache, dizziness, numbness, forgetfulness, difficulty concentrating, blurred vision, muscle spasms, nausea, and difficulty breathing. Frequencies compared between active and sham conditions using McNemar's test.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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