Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS), Sham Bilateral Cerebellar tDCS.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis: A Randomized Controlled Trial Study
Overview
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
Detailed description
Multiple sclerosis (MS) is a chronic immune-mediated neurological disorder characterized by demyelination and neurodegeneration within the central nervous system. Disruption of cerebro-cerebellar networks is a key feature of MS and contributes to impairments in motor coordination, balance, gait, fatigue, and cognitive performance. Cerebellar involvement is particularly associated with ataxia and postural instability, which significantly affect functional independence and quality of life.
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique capable of modulating cortical and cerebellar excitability. Previous studies investigating cerebellar tDCS in MS have reported variable findings, which may be related to heterogeneity in stimulation protocols, the predominant use of unilateral stimulation approaches, and the frequent combination of stimulation with task-oriented rehabilitation. These factors limit the ability to isolate the independent effects of neuromodulation.
The cerebellum operates through bilateral cerebro-cerebellar loops, suggesting that bilateral stimulation may provide more comprehensive modulation of these distributed networks compared to unilateral approaches. In addition, the effects of tDCS are influenced by state-dependent factors, including concurrent motor activity. Delivering stimulation as a standalone intervention allows for clearer evaluation of its direct neuromodulatory effects without the confounding influence of concurrent rehabilitation.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the effects of bilateral cerebellar tDCS on multidomain dysfunction in individuals with MS. Participants will be randomly assigned to receive either active or sham stimulation. The intervention consists of repeated sessions of bilateral cerebellar stimulation delivered over a two-week period using a standardized protocol.
The study aims to evaluate the effects of this intervention on motor and non-motor domains and to explore associated neurophysiological changes. By isolating the effects of bilateral cerebellar stimulation, this trial seeks to provide a clearer understanding of its therapeutic potential and to inform the development of targeted neuromodulation strategies in MS rehabilitation.
Interventions
- Device Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)
Bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using a constant-current stimulator. Anodal electrodes (5 × 5 cm; 25 cm²) will be positioned bilaterally over the cerebellar hemispheres (approximately 3 cm lateral to the inion), with reference electrodes placed over the buccinator muscles. Stimulation will be applied at 2 mA for 20 minutes per session. Participants will receive five sessions per week for two consecutive weeks (total of 10 sessions). - Device Sham Bilateral Cerebellar tDCS
Sham bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using the same electrode placement as the active condition. The current will be ramped up and down at the beginning and end of the session to mimic the sensation of stimulation without delivering continuous current. Each session will last 20 minutes, with five sessions per week for two consecutive weeks (total of 10 sessions).
Primary outcome measures
- Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: 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.]
Secondary outcome measures (12)
- The balance evaluation systems test (mini-BESTest) [Time frame: 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.]
- Timed Up and Go (TUG) [Time frame: 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.]
- Six-Minute Walk Test (6MWT) [Time frame: 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.]
- Modified Tardieu Scale (MTS) [Time frame: 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.]
- Modified Fatigue Impact Scale (MFIS) [Time frame: 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.]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: 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.]
- Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time frame: 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.]
- Symbol Digit Modalities Test (SDMT) [Time frame: 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.]
- Montreal Cognitive Assessment (MoCA) [Time frame: 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.]
- Resting-State EEG [Time frame: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]
- Motor Evoked Potential (MEP) Amplitude [Time frame: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]
- Resting Motor Threshold (RMT) [Time frame: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United Arab Emirates · 1 center
- University of Sharjah — Sharjah city
Identifiers
NCT: NCT07555379 · 080412026 · 080422026