tDCS for Multiple System Atrophy With Cerebellar Feature

NCT ID: NCT04092556

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Multiple System Atrophy, Cerebellar Variant (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tDCS (M1)

The participants will be submit to tDCS applied over the motor cortex (M1)

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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.

tDCS (Cerebellar cortex)

The participants will be submit to tDCS applied over the cerebellar cortex

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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.

Sham stimulation

The participants will be submit to sham stimulation

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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.

Interventions

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transcranial direct current stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jinyoung Youn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinyoung Youn

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Department of Neurology

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jinyoung Youn

Role: CONTACT

82-2-3410-0245

Jong Hyeon Ahn

Role: CONTACT

82-2-3410-0245

Facility Contacts

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Jinyoung Youn

Role: primary

82-2-3410-0245

Other Identifiers

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2018-10-010-002

Identifier Type: -

Identifier Source: org_study_id

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