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

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ClinicalTrials.gov Identifier: NCT01883310
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01883310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Task-oriented Circuit Training Combined With Cerebellar tDCS in Multiple Sclerosis Subjects
Official Title  ICMJE 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
Brief 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis Subjects
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: sham tDCS + TOCT
  • 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.
    Intervention: Device: real tDCS +TOCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)
40
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883310
Other Study ID Numbers  ICMJE TOCT_MS_cerebellar tDCS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sofia Straudi, MD, University Hospital of Ferrara
Study Sponsor  ICMJE University Hospital of Ferrara
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nino Basaglia, MD Ferrara University Hospital
PRS Account University Hospital of Ferrara
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP