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The Effects of a Task-oriented Circuit Training Combined With Cerebellar Transcranial Direct Current Stimulation on Locomotor Function, Balance and Mobility in Multiple Sclerosis Subjects
Sponsor study identifier
interventional
30
1 country
1
Study Start
February 1, 2017
Actual (reported)Primary Completion
July 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2013
Actual (reported)June 21, 2013
Actual (reported)February 1, 2017
Actual (reported)July 1, 2017
Actual (reported)November 1, 2017
Actual (reported)Change from baseline on locomotor function, mobility and balance in multiple sclerosis subjects with gait speed (Timed 25-Foot Walk)
week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
mobility (Timed Up and Go)
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
Balance (Dynamic Gait Index)
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
walking endurance (six minute walking test
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
fatigue (fatigue severity scale)
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
Short Form (36) Health Survey (SF-36)
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
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.
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.
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.
Ferrara University Hospital
Ferrara, 44124, Italy
Nino Basaglia, MD
Ferrara University Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2013
First Posted
June 21, 2013
Study Start
February 1, 2017
Actual (reported)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.
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Primary Completion
July 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)Last Updated
November 20, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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