tDCS for Multiple System Atrophy With Cerebellar Feature

NCT04092556 | Unknown

• 1 other identifier: 2018-10-010-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple System Atrophy, Cerebellar Variant (Disorder)

Keywords

Multiple System Atrophy; Cerebellar Ataxia; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from temporospatial parameters of gait

  per session: at baseline and within 30 minutes tDCS treatment completion

• Change from posturography

  per session: at baseline and within 30 minutes tDCS treatment completion

Study Arms (3)

tDCS (M1)

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

tDCS (Cerebellar cortex)

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

The participants will be submit to sham stimulation

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation 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.

Also known as: tDCS

Sham stimulation; tDCS (Cerebellar cortex); tDCS (M1)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)
• \. Patients aged between 40 and 70
• \. Patients who do not have rigidity and bradykinesia
• \. Patients who have given voluntary consent after understanding the content of the clinical trial

You may not qualify if:

• \. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
• \. Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease
• \. 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
• \. 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy; Cerebellar Ataxia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebellar Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jinyoung Youn

  Samsung Medical Center, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinyoung Youn

CONTACT

82-2-3410-0245; genian@skku.edu

Jong Hyeon Ahn

CONTACT

82-2-3410-0245; jonghyeon.ahn@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 17, 2019
• Study Start: October 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)