Multiple System Atrophy, Cerebellar Variant (Disorder)NCT04092556
tDCS for Multiple System Atrophy With Cerebellar Feature
A study testing transcranial direct current stimulation in people with Multiple System Atrophy, Cerebellar Variant (Disorder), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Multiple System Atrophy, Cerebellar Variant (Disorder)
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2019to Oct 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who meet the clinical criteria for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy)
- 2. Patients aged between 40 and 70
- 3. Patients who do not have rigidity and bradykinesia
- 4. Patients who have given voluntary consent after understanding the content of the clinical trial
Who cannot join
- 1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
- 2. Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease
- 3. Patients with a serious medical disease
- Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
- Patients with un-controlled high blood pressure or diabetes
- 4. Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Jinyoung Youn, 82-2-3410-0245, genian@skku.edu
About this study
Official title: Exploratory Study to Evaluate the Effective Site for Control of Motor Coordination Function After Transcranial Direct Current Stimulation in Multiple Systemic Atrophy With Cerebellar Feature
The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature
Read the detailed description
Participants receive transcranial direct current stimulation (tDCS) over M1, cerebellar cortex or sham stimulation for 30 minutes. The type of stimulation depends on random assignment. The participants have a 1 week of wash out period between each stimulation.
The assessment will be done by International Cooperative Ataxia Rating Scale (ICARS), GAITRITE (CIR Systems Inc., Clifton, New Jersey, USA) and PEDOSCAN (DIERS PEDO, Germany) at baseline and immediately after each treatment.
- Being tested
- transcranial direct current stimulation
- Keywords
- Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation
- Medical subject headings
- Multiple System Atrophy, Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS
tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability.
| Study group | Role | What they receive |
|---|---|---|
| tDCS (M1) | Active comparator | The participants will be submit to tDCS applied over the motor cortex (M1) Receives: Device: transcranial direct current stimulation |
| tDCS (Cerebellar cortex) | Active comparator | The participants will be submit to tDCS applied over the cerebellar cortex Receives: Device: transcranial direct current stimulation |
| Sham stimulation | Sham comparator | The participants will be submit to sham stimulation Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from International Cooperative Ataxia Rating Scale (ICARS)
The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.
Measured: per session: at baseline and within 30 minutes tDCS treatment completion
Secondary outcomes (2)
Change from temporospatial parameters of gait
Gait parameters measured by GAITRite system
Measured: per session: at baseline and within 30 minutes tDCS treatment completion
Change from posturography
Posturography measured by Pedoscan system
Measured: per session: at baseline and within 30 minutes tDCS treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy, Cerebellar Variant (Disorder)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyoung Youn, Samsung Medical Center
- Investigators
- Jinyoung Youn, Principal investigator, Samsung Medical Center, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092556
- Sponsor's protocol ID
- 2018-10-010-002
- Status last verified
- Sep 2019
- First submitted
- 8 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Effective Site for Control of Motor Coordination Function After Transcranial Direct Current Stimulation in Multiple Systemic Atrophy With Cerebellar Feature
- ClinicalTrials.gov ID
- NCT04092556
- Acronym / sponsor ID
- 2018-10-010-002
- Keywords
- Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 17 Sep 2019 (actual)
- 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.
The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature
Detailed description
Participants receive transcranial direct current stimulation (tDCS) over M1, cerebellar cortex or sham stimulation for 30 minutes. The type of stimulation depends on random assignment. The participants have a 1 week of wash out period between each stimulation.
The assessment will be done by International Cooperative Ataxia Rating Scale (ICARS), GAITRITE (CIR Systems Inc., Clifton, New Jersey, USA) and PEDOSCAN (DIERS PEDO, Germany) at baseline and immediately after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS (M1) | Active comparator | Device: transcranial direct current stimulationThe participants will be submit to tDCS applied over the motor cortex (M1) |
| tDCS (Cerebellar cortex) | Active comparator | Device: transcranial direct current stimulationThe participants will be submit to tDCS applied over the cerebellar cortex |
| Sham stimulation | Sham comparator | Device: transcranial direct current stimulationThe participants will be submit to sham stimulation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients who meet the clinical criteria for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy)
- 2. Patients aged between 40 and 70
- 3. Patients who do not have rigidity and bradykinesia
- 4. Patients who have given voluntary consent after understanding the content of the clinical trial
Key exclusion criteria (6 listed)
- 1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
- 2. Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease
- 3. Patients with a serious medical disease
- 4. Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
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 |
|---|---|---|
| transcranial direct current stimulationAlso: tDCStDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. | Device | Sham stimulation, tDCS (Cerebellar cortex), tDCS (M1) |
Primary outcome
Change from International Cooperative Ataxia Rating Scale (ICARS)
Time frame: per session: at baseline and within 30 minutes tDCS treatment completion
The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.
2 secondary outcomes
Change from temporospatial parameters of gait
Time frame: per session: at baseline and within 30 minutes tDCS treatment completion
Change from posturography
Time frame: per session: at baseline and within 30 minutes tDCS treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- 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.
Jinyoung Youn principal investigator
Samsung Medical Center, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Multiple System Atrophy, Cerebellar Variant (Disorder), run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinyoung Youn (82-2-3410-0245, genian@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from International Cooperative Ataxia Rating Scale (ICARS) (time frame: per session: at baseline and within 30 minutes tDCS treatment completion). 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 17 Sep 2019.