Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis: A Randomized Controlled Trial Study

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07555379

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)

Placebo

  • Sham Bilateral Cerebellar tDCS

What it measured

Main measures

  • Scale for the Assessment and Rating of Ataxia (SARA)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after completion of the 10-session intervention), and at 4-week follow-up.

    Walking and mobilityPhysical function

Other measures (12)

  • The balance evaluation systems test (mini-BESTest)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Walking and mobility
  • Timed Up and Go (TUG)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Walking and mobility
  • Six-Minute Walk Test (6MWT)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Walking and mobility
  • Modified Tardieu Scale (MTS)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Spasticity
  • Modified Fatigue Impact Scale (MFIS)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Thinking and memoryFatigue
  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Mood and sleep
  • Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Quality of life (reported by participants)
  • Symbol Digit Modalities Test (SDMT)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Thinking and memory
  • Montreal Cognitive Assessment (MoCA)

    Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.

    Thinking and memory
  • Resting-State EEG

    Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).

    Thinking and memoryNerve conduction tests

Who could take part

MS (type not specified) · 18 and over · EDSS 2.0 to 6.0

Show the full criteria

Inclusion criteria

* Confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria * Adult Age > 18 years * Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0 * Clinically stable disease status for at least 3 months prior to enrollment * On stable disease-modifying therapy (DMT) for at least 3 months * Ability to understand study procedures and provide informed consent * Ability to ambulate independently or with assistive devices sufficient to complete motor assessments

Exclusion criteria

* Multiple sclerosis relapse within the past 3 months * History of epilepsy or seizures * Presence of implanted electronic devices (e.g., pacemaker, neurostimulator) * Metallic implants in the head or skull incompatible with transcranial magnetic stimulation (TMS) * Severe cognitive impairment preventing participation in assessments * Pregnancy or planned pregnancy during the study period * Other neurological or psychiatric disorders that may confound study outcomes * Severe musculoskeletal or orthopedic conditions interfering with motor performance testing * Contraindications to non-invasive brain stimulation or TMS

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The goal of this clinical trial is to learn if brain stimulation can improve movement and daily function in people with multiple sclerosis (MS). The study will also look at how this treatment affects fatigue, sleep, memory and attention, and quality of life. The main questions this study aims to answer are the following: Does this treatment improve coordination and balance? Does it reduce fatigue and improve sleep and daily life? Does it change brain activity? Researchers will compare active brain stimulation to sham stimulation (a look-alike treatment that does not deliver real stimulation) to see if the treatment works. Participants will: Receive brain stimulation sessions for two weeks Attend assessment sessions before and after treatment Return for a follow-up visit after four weeks Complete tests of movement, fatigue, sleep, and thinking

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History

    1. Started

      Sept 2026

    2. Main results due

      Mar 2028

    3. Finished

      Jun 2028

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