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
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
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)
Parallel
Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)
DeviceBilateral 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
DeviceSham 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).
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.
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.
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.
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.
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).
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This trial is not recruiting at the moment. You can still explore other options:
