Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 2, 2026
CompletedJuly 2, 2026
June 1, 2026
1.1 years
June 23, 2026
June 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Modified Fatigue Impact Scale (MFIS) - Total Score
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
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
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
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
Secondary Outcomes (7)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Baseline, Day 5, Day 26
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
Baseline, Day 5, Day 26
Visual Analog Scale (VAS) - Fatigue
Baseline, Day 5, Day 26
Visual Analog Scale (VAS) - Depression
Baseline, Day 5, Day 26
Symbol Digit Modalities Test (SDMT)
Baseline, Day 5, Day 26
- +2 more secondary outcomes
Other Outcomes (1)
Adverse events - frequency and type
After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)
Study Arms (2)
Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
EXPERIMENTALActive, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
Sham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
SHAM COMPARATORSham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
Interventions
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 Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurociencia Clínica Integral
Mexico City, 11580, Mexico
Related Publications (5)
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.
PMID: 22799620BACKGROUNDHsu 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.
PMID: 33763014BACKGROUNDBikson 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.
PMID: 27372845BACKGROUNDStagg CJ, Antal A, Nitsche MA. Physiology of Transcranial Direct Current Stimulation. J ECT. 2018 Sep;34(3):144-152. doi: 10.1097/YCT.0000000000000510.
PMID: 29877965BACKGROUNDCompston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
PMID: 11955556BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ASDRUBAL R HUERTA GALLANGO, MD / PhD
Universidad de Almeria
- PRINCIPAL INVESTIGATOR
Luis Fernando Sánchez-Santed, PhD
Universidad de Almeria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invetigator
Study Record Dates
First Submitted
June 23, 2026
First Posted
July 2, 2026
Study Start
August 1, 2023
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Starting 3 months following publication of the primary manuscript; available for at least 5 years thereafter.
- Access Criteria
- Researchers with a methodologically sound research proposal and a signed data access agreement with the corresponding institution. Requests submitted to the corresponding author.
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.