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

NCT07555379 | Not Yet Recruiting

• 2 other identifiers: 080412026080422026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Multiple Sclerosis

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

Outcome Measures

Primary Outcomes (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.

  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)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Sham Bilateral Cerebellar tDCS

SHAM COMPARATOR

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

TDCS GROUP

EXPERIMENTAL

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)

Interventions

Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS) DEVICE

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).

Also known as: Cerebellar tDCS

TDCS GROUP

Sham Bilateral Cerebellar tDCS DEVICE

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).

Sham Bilateral Cerebellar tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

MeSH Terms

Conditions

Multiple Sclerosis; Ataxia; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Hikmat hadoush

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hikmat Hadoush PhD, PhD

CONTACT

+971561445325; hhadoush@sharjah.ac.ae

Hikmat Hadoush Associate Professor, Associate Professor

CONTACT

00971561445325; hhadoush@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study will employ a double-blind design with additional blinding of outcome assessors. Participants and care providers administering the stimulation will be blinded to group allocation through the use of identical stimulation procedures in both active and sham conditions. The tDCS device will be pre-programmed to deliver either active or sham stimulation, ensuring allocation concealment. Investigators involved in data analysis and outcome assessors conducting clinical evaluations will remain blinded to group assignment throughout the study to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

AE (1)