tDCS for Multiple System Atrophy With Cerebellar Feature

Samsung Medical Center

Status: Unknown

Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04092556

2018-10-010-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups

tDCS (M1)

Active Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation

tDCS (Cerebellar cortex)

Active Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation

Sham stimulation

Sham Comparator group

Description:

The participants will be submit to sham stimulation

Treatment:

Device: transcranial direct current stimulation