tDCS for Multiple System Atrophy With Cerebellar Feature

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

Study Overview

• Status: Unknown
• Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)
• Intervention / Treatment: Device: transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinyoung Youn; Phone Number: 82-2-3410-0245; Email: genian@skku.edu
• Study Contact Backup: Name: Jong Hyeon Ahn; Phone Number: 82-2-3410-0245; Email: jonghyeon.ahn@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Jinyoung Youn; Phone Number: 82-2-3410-0245; Email: genian@skku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	per session: at baseline and within 30 minutes tDCS treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from temporospatial parameters of gait	Gait parameters measured by GAITRite system	per session: at baseline and within 30 minutes tDCS treatment completion
Change from posturography	Posturography measured by Pedoscan system	per session: at baseline and within 30 minutes tDCS treatment completion

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jinyoung Youn, Samsung Medical Center, Department of Neurology

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Multiple System Atrophy; Cerebellar Ataxia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Atrophy; Multiple System Atrophy; Shy-Drager Syndrome
• Other Study ID Numbers: 2018-10-010-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No