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Multiple SclerosisCerebellertDCSNCT07555379

Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis

A study testing Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS) in people with Multiple Sclerosis, run by University of Sharjah at 1 site in United Arab Emirates.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Sep 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hikmat Hadoush PhD, PhD contact

+971561445325

hhadoush@sharjah.ac.ae

Hikmat Hadoush Associate Professor, Associate Professor contact

00971561445325

hhadoush@sharjah.ac.ae

United Arab Emirates1 site
  • University of Sharjah

    Sharjah city

Other trials in United Arab Emirates

About this study

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

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:

Read more

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

Read the 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.

Being tested
Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS), Sham Bilateral Cerebellar tDCS
Keywords
Multiple sclerosis, cerebellar transcranial direct current stimulation, ctDCS, bilateral cerebellar stimulation, neuromodulation, ataxia, balance, gait, fatigue, cognition, sleep quality, quality of life, EEG, transcranial magnetic stimulation, corticospinal excitability, neurorehabilitation
Medical subject headings
Multiple Sclerosis, Ataxia, Fatigue, Sleep Initiation and Maintenance Disorders

What participants receive

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

  • Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)Device

    Also called Cerebellar tDCS

    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).

  • Sham Bilateral Cerebellar tDCSDevice

    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).

Study groups in NCT07555379
Study groupRoleWhat they receive
Sham Bilateral Cerebellar tDCSSham comparatorParticipants in this arm will receive sham bilateral cerebellar transcranial direct current stimulation (ctDCS). Electrodes will be positioned identically to the active stimulation group (bilateral cerebellar montage). The device will deliver a brief ramp-up and ramp-down of current at the beginning and end of the session to mimic the sensation of active stimulation, but no continuous current will be applied. Each session will last 20 minutes, 5 sessions per week for 2 consecutive weeks (total of 10 sessions). This procedure is designed to maintain participant blinding.
Receives: Device: Sham Bilateral Cerebellar tDCS
TDCS GROUPExperimentalParticipants in this arm will receive bilateral cerebellar transcranial direct current stimulation (ctDCS). Anodal electrodes will be positioned bilaterally over the cerebellar hemispheres (3 cm lateral to the inion), with reference electrodes placed over the buccinator muscles. Stimulation will be delivered at 2 mA for 20 minutes per session, 5 sessions per week for 2 consecutive weeks (total of 10 sessions). The intervention will be administered as a standalone neuromodulation protocol without concurrent task-oriented rehabilitation to isolate neuro-modulatory effects.
Receives: Device: Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)

What is being measured

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

  1. Scale for the Assessment and Rating of Ataxia (SARA)

    The Scale for the Assessment and Rating of Ataxia (SARA) is an 8-item clinical scale used to assess cerebellar ataxia, including gait, stance, sitting balance, speech, and limb coordination.

    Total scores range from 0 (no ataxia) to 40 (most severe ataxia), where higher scores indicate worse ataxia.

    Measured: 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 outcomes (12)
  1. The balance evaluation systems test (mini-BESTest)

    The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a 14-item clinical scale assessing dynamic balance, including anticipatory control, reactive responses, sensory orientation, and gait stability.

    Total scores range from 0 (severe balance impairment) to 28 (normal balance), where higher scores indicate better balance performance.

    Measured: 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.

  2. Timed Up and Go (TUG)

    The Timed Up and Go (TUG) test measures functional mobility as the time required to stand up from a chair, walk 3 meters, turn, return, and sit down.

    Measured in seconds (s), with no fixed minimum or maximum values, where lower times indicate better functional mobility.

    Measured: 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.

  3. Six-Minute Walk Test (6MWT)

    The Six-Minute Walk Test (6MWT) assesses walking endurance by measuring the total distance walked over 6 minutes.

    Measured in meters (m), with no fixed maximum value, where higher distances indicate better functional performance.

    Measured: 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.

  4. Modified Tardieu Scale (MTS)

    The Modified Tardieu Scale (MTS) assesses spasticity by measuring muscle response to passive stretch at different velocities, including angle of muscle reaction and quality of response.

    Scoring depends on joint and muscle group assessed and does not have a single fixed total score range; however, higher scores indicate greater spasticity (worse outcome).

    Measured: 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.

  5. Modified Fatigue Impact Scale (MFIS)

    The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire assessing the impact of fatigue on physical, cognitive, and psychosocial function.

    Total scores range from 0 (no fatigue impact) to 84 (maximum fatigue impact), where higher scores indicate worse fatigue.

    Measured: 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.

  6. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances over the past month.

    Total scores range from 0 (good sleep quality) to 21 (poor sleep quality), where higher scores indicate worse sleep quality.

    Measured: 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.

  7. Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a multidimensional questionnaire assessing health-related quality of life, including physical and mental health domains.

    Composite scores range from 0 (poor quality of life) to 100 (best quality of life), where higher scores indicate better quality of life.

    Measured: 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.

  8. Symbol Digit Modalities Test (SDMT)

    The Symbol Digit Modalities Test (SDMT) assesses cognitive processing speed by measuring the number of correct symbol-digit pairings completed within a fixed time period.

    Scores are reported as the number of correct responses, with no fixed maximum value, where higher scores indicate better cognitive performance.

    Measured: 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.

  9. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a screening tool for global cognitive function, including attention, memory, executive function, and visuospatial ability.

    Total scores range from 0 (severe impairment) to 30 (normal cognition), where higher scores indicate better cognitive function.

    Measured: 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.

  10. Resting-State EEG

    Resting-state electroencephalography (EEG) will be used to assess cortical activity and neural oscillatory dynamics. Quantitative EEG analysis will be performed using power spectral density (PSD) to evaluate frequency-specific activity across standard frequency bands, including delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13-30 Hz).Measured in microvolts squared (µV²), with no fixed minimum or maximum values, where changes

    Absolute and relative power within each frequency band will be calculated. In addition, regional analysis (frontal, central, parietal regions) may be conducted to examine spatial distribution of cortical activity.

    Changes in EEG power spectral density are interpreted as indicators of altered cortical excitability and functional brain activity. For example, increases in alpha power may reflect improved neural efficiency and network organization, whereas changes in theta or beta activity may indicate modulation of cognitive and sensorimotor processes.

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

  11. Motor Evoked Potential (MEP) Amplitude

    Motor evoked potential (MEP) amplitude, measured using transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), reflects corticospinal excitability.

    Values are expressed in millivolts (mV), with no fixed minimum or maximum values, where higher values indicate greater corticospinal excitability.

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

  12. Resting Motor Threshold (RMT)

    Resting motor threshold (RMT), measured using transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), represents the minimum stimulation intensity required to elicit a motor response at rest.

    Values are expressed as a percentage of maximum stimulator output (%), with no fixed minimum or maximum values, where lower values indicate greater corticospinal excitability.

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

Timeline

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

  1. First posted29 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

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
Parallel groups
Model description
This study is a randomized, double-blind, sham-controlled, parallel-group trial. Participants will be randomly allocated to either an active bilateral cerebellar transcranial direct current stimulation (ctDCS) group or a sham stimulation group in a 1:1 ratio. The parallel design allows for direct comparison of outcomes between groups to evaluate the efficacy of bilateral cerebellar neuromodulation in individuals with multiple sclerosis.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555379
Sponsor's protocol ID
080412026
Other IDs
080422026
Acronym
CerebellertDCS
Status last verified
Apr 2026
First submitted
14 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS) in people with Multiple Sclerosis, run by University of Sharjah at 1 site in United Arab Emirates.

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 7 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: opening soon, as of the sponsor's last update on 29 Apr 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 United Arab Emirates. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hikmat Hadoush PhD, PhD (+971561445325, hhadoush@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2026.

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CerebellertDCS Clinical Trial NCT07555379 | AzTrials