Task-oriented Circuit Training Combined With Cerebellar tDCS in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis Subjects
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Aims of the study:

      This is a double-blind randomized-controlled trial to test the effects of a task oriented
      training combined with cerebellar transcranial direct current stimulation on locomotor
      function, mobility and balance in multiple sclerosis subjects with moderate gait impairments
      (EDSS 4-5,5).

      Subjects and methods: 30 multiple sclerosis patients will be recruited in an outpatient
      rehabilitation clinic University Hospital Ferrara. Informed consent will be obtained.
      Participants enrolled will included in 2 different treatment groups: Task Oriented Circuit
      Training (TOCT) + anodal cerebellar transcranial direct current stimulation (experimental
      group) and TOCT + sham transcranial direct current stimulation over the cerebellum (control
      group). The group with anodal transcranial direct current stimulation will receive continuous
      stimulation with intensity of 2 mA during the first 15 minutes of functional circuit
      training. In the sham session, anodal transcranial direct current stimulation was applied for
      30 s and then shut off. Each subject will receive 10 task-oriented training sessions over 2
      weeks (5 sessions/week). 3 subjects with a supervisor physiotherapist will take part at the
      TOCT. During the stimulation sessions both the subject and the researcher, responsible for
      carrying out clinical tests, will be unaware of the type of stimulation set.

      Treatment efficacy outcome measures will be clinical test for gait speed (Timed 25-Foot
      Walk), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility
      (Time Up and Go Test); self-assessment questionnaire for motor fatigue (Fatigue Severity
      Scale FSS) and quality of life (Short Form (36) Health Survey).

      Outcome measures will be assessed the week prior to treatment initiation (T0), the week after
      the end of treatment (T1) and at 3 months follow-up (T3) to evaluate treatments retention, by
      a clinician blinded to the treatment. At the end of each session, the subject will complete a
      questionnaire where report side effects due to stimulation (headache, neck pain, burning,
      redness and/or itching in the site of stimulation).
    

Detailed description: 
      The inclusion criteria will be:

        -  males and females, community dwelling, age 18 or older;

        -  diagnosis of multiple sclerosis in a stable phase, which will be defined as a chronic
           progressive or relapsing-remitting pattern with no relapse during the last 3 months;

        -  moderate gait impairments referred to Expanded Disability Status Scale between 4 and 5,5
           (this EDSS scores refers to people with restricted ambulation who do not need walking
           aids).
    

Intervention name(s): sham tDCS + TOCT; real tDCS +TOCT
Intervention type(s): Device; Device
Intervention description(s): Anodal transcranial direct current stimulation will be delivered through 2 sponge electrodes (surface area: 25 cm2) soaked in a saline solution. For the cerebellar transcranial direct current stimulation, the anodal electrode will be centered on the right cerebellar cortex, 3 cm lateral to the inion, and the cathodal electrode will be positioned on the right buccinator muscle. Anodal stimulation intensity will be set at 2 mili Ampere and delivered using a rechargeable batteries direct current stimulator.The sham transcranial direct current stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 s over the right cerebellar position.; Anodal transcranial direct current stimulation will be delivered through 2 sponge electrodes (surface area: 25 cm2) soaked in a saline solution. For the cerebellar transcranial direct current stimulation, the anodal electrode will be centered on the right cerebellar cortex, 3 cm lateral to the inion, and the cathodal electrode will be positioned on the right buccinator muscle. Anodal stimulation intensity will be set at 2 mili Ampere and delivered using a rechargeable batteries direct current stimulator.The real transcranial direct current stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 15 minutes over the right cerebellar position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; transcranial direct current stimulation; TOCT; task-oriented circuit training; locomotor function; mobility; balance