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

29. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

38

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
Enhet: 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
Enhet: Sham transcranial direct current stimulation simulation
Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad de Almeria

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2023

Primær fullføring (Faktiske)

30. august 2024

Studiet fullført (Faktiske)

30. august 2024

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TDCSMS-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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