Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis
29 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Mexico City, México, 11580
- Neurociencia Clínica Integral
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
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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).
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Comparador falso: Sham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
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Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Modified Fatigue Impact Scale (MFIS) - Total Score
Periodo de tiempo: 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)
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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.
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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)
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Modified Fatigue Impact Scale (MFIS) - Physical Subscale
Periodo de tiempo: Baseline, Day 5, Day 26
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Physical subscale of the MFIS (9 items; range 0-36).
Assesses impact of fatigue on physical functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale
Periodo de tiempo: Baseline, Day 5, Day 26
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Cognitive subscale of the MFIS (10 items; range 0-40).
Assesses impact of fatigue on cognitive functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale
Periodo de tiempo: Baseline, Day 5, Day 26
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Psychosocial subscale of the MFIS (2 items; range 0-8).
Assesses impact of fatigue on psychosocial functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Visual Analog Scale (VAS) - Fatigue
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Visual Analog Scale (VAS) - Depression
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Symbol Digit Modalities Test (SDMT)
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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California Verbal Learning Test-II (CVLT-II)
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Brief Visuospatial Memory Test-Revised (BVMT-R)
Periodo de tiempo: Baseline, Day 5, Day 26
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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.
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Baseline, Day 5, Day 26
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adverse events - frequency and type
Periodo de tiempo: After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)
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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.
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After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: ASDRUBAL R HUERTA GALLANGO, MD / PhD, Universidad de Almeria
- Investigador principal: Luis Fernando Sánchez-Santed, PhD, Universidad de Almeria
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Stagg CJ, Antal A, Nitsche MA. Physiology of Transcranial Direct Current Stimulation. J ECT. 2018 Sep;34(3):144-152. doi: 10.1097/YCT.0000000000000510.
- Benedict RH, Amato MP, Boringa J, Brochet B, Foley F, Fredrikson S, Hamalainen P, Hartung H, Krupp L, Penner I, Reder AT, Langdon D. Brief International Cognitive Assessment for MS (BICAMS): international standards for validation. BMC Neurol. 2012 Jul 16;12:55. doi: 10.1186/1471-2377-12-55.
- Hsu WY, Cheng CH, Zanto TP, Gazzaley A, Bove RM. Effects of Transcranial Direct Current Stimulation on Cognition, Mood, Pain, and Fatigue in Multiple Sclerosis: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Mar 8;12:626113. doi: 10.3389/fneur.2021.626113. eCollection 2021.
- Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2023
Finalización primaria (Actual)
30 de agosto de 2024
Finalización del estudio (Actual)
30 de agosto de 2024
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2026
Publicado por primera vez (Actual)
2 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Esclerosis múltiple
- Fatiga
- Esclerosis Múltiple Recurrente-Remitente
- Esclerosis Múltiple Crónica Progresiva
- Terapéutica
- Disciplinas y actividades de comportamiento
- Terapia de estimulación eléctrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- Electrochoque
- Técnicas psicológicas
- Estimulación de corriente continua transcraneal
Otros números de identificación del estudio
- TDCSMS-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Starting 3 months following publication of the primary manuscript; available for at least 5 years thereafter.
Criterios de acceso compartido de IPD
Researchers with a methodologically sound research proposal and a signed data access agreement with the corresponding institution.
Requests submitted to the corresponding author.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .