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tDCS for Multiple System Atrophy With Cerebellar Feature

Primary Purpose

Multiple System Atrophy, Cerebellar Variant (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy, Cerebellar Variant (Disorder) focused on measuring Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

tDCS (M1)

tDCS (Cerebellar cortex)

Sham stimulation

Arm Description

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

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

The participants will be submit to sham stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from temporospatial parameters of gait
Gait parameters measured by GAITRite system
Change from posturography
Posturography measured by Pedoscan system

Full Information

First Posted
September 8, 2019
Last Updated
September 16, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04092556
Brief Title
tDCS for Multiple System Atrophy With Cerebellar Feature
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy, Cerebellar Variant (Disorder)
Keywords
Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS (M1)
Arm Type
Active Comparator
Arm Description
The participants will be submit to tDCS applied over the motor cortex (M1)
Arm Title
tDCS (Cerebellar cortex)
Arm Type
Active Comparator
Arm Description
The participants will be submit to tDCS applied over the cerebellar cortex
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
The participants will be submit to sham stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from International Cooperative Ataxia Rating Scale (ICARS)
Description
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.
Time Frame
per session: at baseline and within 30 minutes tDCS treatment completion
Secondary Outcome Measure Information:
Title
Change from temporospatial parameters of gait
Description
Gait parameters measured by GAITRite system
Time Frame
per session: at baseline and within 30 minutes tDCS treatment completion
Title
Change from posturography
Description
Posturography measured by Pedoscan system
Time Frame
per session: at baseline and within 30 minutes tDCS treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinyoung Youn
Phone
82-2-3410-0245
Email
genian@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Hyeon Ahn
Phone
82-2-3410-0245
Email
jonghyeon.ahn@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyoung Youn
Organizational Affiliation
Samsung Medical Center, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinyoung Youn
Phone
82-2-3410-0245
Email
genian@skku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS for Multiple System Atrophy With Cerebellar Feature

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