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

This study is currently recruiting participants.
Verified February 2017 by Sofia Straudi, MD, University Hospital of Ferrara
Sponsor:
ClinicalTrials.gov Identifier:
NCT01883310
First Posted: June 21, 2013
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
  Purpose

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).


Condition Intervention
Multiple Sclerosis Subjects Device: sham tDCS + TOCT Device: real tDCS +TOCT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sofia Straudi, MD, University Hospital of Ferrara:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 30
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883310


Contacts
Contact: Carlotta Martinuzzi, PT 0039 0532 238720 costes@alice.it

Locations
Italy
Ferrara University Hospital Recruiting
Ferrara, Italy, 44124
Contact: Carlotta Martinuzzi, PT    0039 0532 8720    costes@alice.it   
Sub-Investigator: Carlotta Martinuzzi, PT         
Sub-Investigator: Marco Da Roit, PT         
Sub-Investigator: Laura Di Marco, PT         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
Principal Investigator: Nino Basaglia, MD Ferrara University Hospital
  More Information

Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01883310     History of Changes
Other Study ID Numbers: TOCT_MS_cerebellar tDCS
First Submitted: June 18, 2013
First Posted: June 21, 2013
Last Update Posted: May 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
Multiple Sclerosis
transcranial direct current stimulation
TOCT
task-oriented circuit training
locomotor function
mobility
balance

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases