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

November 16, 2017 updated by: Sofia Straudi, MD, University Hospital of Ferrara

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Ferrara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • neurologic conditions in addition to multiple sclerosis that may affect motor function;
  • other medical conditions likely to interfere with the ability to safely complete the study protocol;
  • impaired cognitive functioning (Mini Mental Status Examination < 24);
  • contraindications to transcranial direct current stimulation: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sham tDCS + TOCT
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.
Device: sham tDCS + TOCT
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.
Experimental: real tDCS + TOCT
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.
Device: real tDCS +TOCT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline on locomotor function, mobility and balance in multiple sclerosis subjects with gait speed (Timed 25-Foot Walk)
Time Frame: week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)

Secondary Outcome Measures

Outcome Measure
Time Frame
mobility (Timed Up and Go)
Time Frame: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
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)
Time Frame: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
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
Time Frame: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
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)
Time Frame: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
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)
Time Frame: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Nino Basaglia, MD, Ferrara University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOCT_MS_cerebellar tDCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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