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Multiple Sclerosis, MSNCT07680738

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

A study testing Transcranial Direct Current Stimulation in people with Multiple Sclerosis, MS and Multiple Sclerosis, run by Universidad de Almeria at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteMexico
Study dates
1 Aug 2023to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Neurociencia Clínica Integral

    Mexico City, 11580

Other trials in Mexico

About this study

Official title: 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.

Being tested
Transcranial Direct Current Stimulation, Sham transcranial direct current stimulation simulation
Keywords
Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis, Multiple Sclerosis, Fatigue, transcranial direct current stimulation, mood, cognition, non-invasive brain stimulation
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current StimulationDevice

    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 simulationDevice

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

Study groups in NCT07680738
Study groupRoleWhat they receive
Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulationExperimentalActive, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
Receives: Device: Transcranial Direct Current Stimulation
Sham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulationSham comparatorSham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
Receives: Device: Sham transcranial direct current stimulation simulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: Baseline, Day 5, Day 26

  3. 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.

    Measured: Baseline, Day 5, Day 26

  4. 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.

    Measured: Baseline, Day 5, Day 26

Secondary outcomes (7)

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

    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.

    Measured: Baseline, Day 5, Day 26

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

    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.

    Measured: Baseline, Day 5, Day 26

  3. Visual Analog Scale (VAS) - Fatigue

    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.

    Measured: Baseline, Day 5, Day 26

  4. Visual Analog Scale (VAS) - Depression

    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.

    Measured: Baseline, Day 5, Day 26

  5. Symbol Digit Modalities Test (SDMT)

    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.

    Measured: Baseline, Day 5, Day 26

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

    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.

    Measured: Baseline, Day 5, Day 26

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

    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.

    Measured: Baseline, Day 5, Day 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start1 Aug 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680738
Sponsor's protocol ID
TDCSMS-001
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 22799620

  • 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.

    PubMed 33763014

  • 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.

    PubMed 27372845

  • 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.

    PubMed 29877965

  • Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.

    PubMed 11955556

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Multiple Sclerosis, MS and Multiple Sclerosis, run by Universidad de Almeria at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07680738, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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