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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04092556
Enrollment
10
Registered
2019-09-17
Start date
2019-10-01
Completion date
2020-10-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple System Atrophy, Cerebellar Variant (Disorder)

Keywords

Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation

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.

Interventions

DEVICEtranscranial 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from International Cooperative Ataxia Rating Scale (ICARS)per session: at baseline and within 30 minutes tDCS treatment completionThe 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

MeasureTime frameDescription
Change from temporospatial parameters of gaitper session: at baseline and within 30 minutes tDCS treatment completionGait parameters measured by GAITRite system
Change from posturographyper session: at baseline and within 30 minutes tDCS treatment completionPosturography measured by Pedoscan system

Countries

South Korea

Contacts

Primary ContactJinyoung Youn
genian@skku.edu82-2-3410-0245
Backup ContactJong Hyeon Ahn
jonghyeon.ahn@samsung.com82-2-3410-0245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026