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

April 23, 2026 updated by: Hikmat Hadoush, University of Sharjah

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:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hikmat Hadoush Associate Professor, Associate Professor
  • Phone Number: 00971561445325
  • Email: hhadoush@sharjah.ac.ae

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Bilateral Cerebellar tDCS
Participants 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.
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).
Experimental: TDCS GROUP
Participants 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.
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).
Other Names:
  • Cerebellar tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

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.
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.

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.
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.

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).
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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).

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.
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).

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.
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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sharjah

Investigators

  • Principal Investigator: Hikmat hadoush, University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080412026
  • 080422026 (Other Grant/Funding Number: university of Sharjah)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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