Multiple Sclerosis SubjectsNCT01883310
Task-oriented Circuit Training Combined With Cerebellar tDCS in Multiple Sclerosis Subjects
A study testing real tDCS +TOCT in people with Multiple Sclerosis Subjects, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis Subjects
- What is being tested?
- real tDCS +TOCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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).
Read the 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).
- Conditions
- Multiple Sclerosis Subjects
- Being tested
- sham tDCS + TOCT, real tDCS +TOCT
- Keywords
- Multiple Sclerosis, transcranial direct current stimulation, TOCT, task-oriented circuit training, locomotor function, mobility, balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham tDCS + TOCTDevice
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.
real tDCS +TOCTDevice
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 group | Role | What they receive |
|---|---|---|
| sham tDCS + TOCT | Active comparator | 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. Receives: Device: sham tDCS + TOCT |
| real tDCS + TOCT | Experimental | 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. Receives: Device: real tDCS +TOCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on locomotor function, mobility and balance in multiple sclerosis subjects with gait speed (Timed 25-Foot Walk)
Measured: week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
Secondary outcomes (5)
mobility (Timed Up and Go)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: the week prior to treatment initiation (T0), the week after the end oftreatment (T1) and at 3 months follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jul 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
- Investigators
- Nino Basaglia, MD, Principal investigator, Ferrara University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883310
- Sponsor's protocol ID
- TOCT_MS_cerebellar tDCS
- Status last verified
- Nov 2017
- First submitted
- 18 Jun 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01883310
- Acronym / sponsor ID
- TOCT_MS_cerebellar tDCS
- Conditions
- Multiple Sclerosis Subjects
- Keywords
- Multiple Sclerosis, transcranial direct current stimulation, TOCT, task-oriented circuit training, locomotor function, mobility, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS + TOCT | Active comparator | Device: sham tDCS + TOCTThe 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. |
| real tDCS + TOCT | Experimental | Device: real tDCS +TOCTthe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham tDCS + TOCTAnodal 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 | sham tDCS + TOCT |
| real tDCS +TOCTAnodal 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. | Device | real tDCS + TOCT |
Primary outcome
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)
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Basaglia, MD principal investigator
Ferrara University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tDCS +TOCT in people with Multiple Sclerosis Subjects, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.