NCT01883310

Task-oriented Circuit Training Combined With Cerebellar tDCS in Multiple Sclerosis Subjects

Completed NA Last updated 20 November 2017

What this trial tests

NA trial testing sham tDCS + TOCT in Multiple Sclerosis Subjects in 30 participants. Completed in 1 November 2017.

Timeline

1 February 2017

Primary endpoint
1 July 2017

1 November 2017

Quick facts

Lead sponsor	University Hospital of Ferrara
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 February 2017
Primary completion	1 July 2017
Estimated completion	1 November 2017
Sites	1 location across Italy

Drugs / interventions tested

• sham tDCS + TOCT
• real tDCS +TOCT

Conditions studied

• Multiple Sclerosis Subjects — all drugs for Multiple Sclerosis Subjects →

Sponsor

University Hospital of Ferrara

Who can join

Adults 18 to 75, any sex, with Multiple Sclerosis Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.