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Trial record 24 of 91 for:    "Brain Diseases" AND "Multiple System Atrophy"

tDCS for Multiple System Atrophy With Cerebellar Feature

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ClinicalTrials.gov Identifier: NCT04092556
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jinyoung Youn, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Multiple System Atrophy, Cerebellar Variant (Disorder) Device: transcranial direct current stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tDCS (M1)
The participants will be submit to tDCS applied over the motor cortex (M1)
Device: 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.
Other Name: tDCS

Active Comparator: tDCS (Cerebellar cortex)
The participants will be submit to tDCS applied over the cerebellar cortex
Device: 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.
Other Name: tDCS

Sham Comparator: Sham stimulation
The participants will be submit to sham stimulation
Device: 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.
Other Name: tDCS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from temporospatial parameters of gait [ Time Frame: per session: at baseline and within 30 minutes tDCS treatment completion ]
    Gait parameters measured by GAITRite system

  2. Change from posturography [ Time Frame: per session: at baseline and within 30 minutes tDCS treatment completion ]
    Posturography measured by Pedoscan system



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04092556


Contacts
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Contact: Jinyoung Youn 82-2-3410-0245 genian@skku.edu
Contact: Jong Hyeon Ahn 82-2-3410-0245 jonghyeon.ahn@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jinyoung Youn    82-2-3410-0245    genian@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jinyoung Youn Samsung Medical Center, Department of Neurology

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Responsible Party: Jinyoung Youn, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04092556     History of Changes
Other Study ID Numbers: 2018-10-010-002
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinyoung Youn, Samsung Medical Center:
Multiple System Atrophy
Cerebellar Ataxia
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases