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

29. juni 2026 opdateret af: Asdrubal Rene Huerta Gallango, Universidad de Almeria

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
      • Mexico City, Mexico, 11580
        • Neurociencia Clínica Integral

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
Enhed: Transcranial 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).
Sham-komparator: Sham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
Enhed: Sham transcranial direct current stimulation simulation
Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Fatigue Impact Scale (MFIS) - Total Score
Tidsramme: 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.
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
Tidsramme: 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.
Baseline, Day 5, Day 26
Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale
Tidsramme: 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.
Baseline, Day 5, Day 26
Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale
Tidsramme: 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.
Baseline, Day 5, Day 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Tidsramme: 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.
Baseline, Day 5, Day 26
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
Tidsramme: 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.
Baseline, Day 5, Day 26
Visual Analog Scale (VAS) - Fatigue
Tidsramme: 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.
Baseline, Day 5, Day 26
Visual Analog Scale (VAS) - Depression
Tidsramme: 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.
Baseline, Day 5, Day 26
Symbol Digit Modalities Test (SDMT)
Tidsramme: 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.
Baseline, Day 5, Day 26
California Verbal Learning Test-II (CVLT-II)
Tidsramme: 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.
Baseline, Day 5, Day 26
Brief Visuospatial Memory Test-Revised (BVMT-R)
Tidsramme: 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.
Baseline, Day 5, Day 26

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events - frequency and type
Tidsramme: 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.
After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Almeria

Efterforskere

  • Ledende efterforsker: ASDRUBAL R HUERTA GALLANGO, MD / PhD, Universidad de Almeria
  • Ledende efterforsker: Luis Fernando Sánchez-Santed, PhD, Universidad de Almeria

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2023

Primær færdiggørelse (Faktiske)

30. august 2024

Studieafslutning (Faktiske)

30. august 2024

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TDCSMS-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) underlying the results reported in the published article will be made available to qualified researchers upon reasonable request. Shared data will include the de-identified clinical dataset (outcome scores at baseline, post-sham, and post-treatment time points for all 33 completers), the statistical analysis plan, and the data dictionary. Requests should be directed to the corresponding author (asdrubalhuerta@gmail.com) and will be reviewed on a case-by-case basis. Data will be shared after deposition of the dataset in an institutional or public repository upon publication of the primary manuscript.

IPD-delingstidsramme

Starting 3 months following publication of the primary manuscript; available for at least 5 years thereafter.

IPD-delingsadgangskriterier

Researchers with a methodologically sound research proposal and a signed data access agreement with the corresponding institution. Requests submitted to the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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