tDCS for Multiple System Atrophy With Cerebellar Feature

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple System Atrophy, Cerebellar Variant (Disorder)

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS (M1)<br>The participants will be submit to tDCS applied over the motor cortex (M1) | Device: transcranial direct current stimulation<br>* 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.<br>* Other names: tDCS;|
| Active Comparator: tDCS (Cerebellar cortex)<br>The participants will be submit to tDCS applied over the cerebellar cortex | Device: transcranial direct current stimulation<br>* 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.<br>* Other names: tDCS;|
| Sham Comparator: Sham stimulation<br>The participants will be submit to sham stimulation | Device: transcranial direct current stimulation<br>* 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.<br>* Other names: tDCS;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple System Atrophy, Cerebellar Ataxia, Transcranial Direct Current Stimulation