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

Sponsor
University of Sharjah
Study ID
NCT07555379
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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

Key Dates

First listed
Apr 29, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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. ]

Central Contacts

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