tDCS for Multiple System Atrophy With Cerebellar Feature

Not Applicable

• Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT04092556
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-17
• Last Update Posted: 2019-09-17
• Study Start: 2019-10-01
• Primary Completion: 2020-05
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	transcranial direct current stimulation	The participants will be submit to sham stimulation
tDCS (M1)	transcranial direct current stimulation	The participants will be submit to tDCS applied over the motor cortex (M1)
tDCS (Cerebellar cortex)	transcranial direct current stimulation	The participants will be submit to tDCS applied over the cerebellar cortex

Primary Outcome Measures

Name	Time	Method
Change from International Cooperative Ataxia Rating Scale (ICARS)	per session: at baseline and within 30 minutes tDCS treatment completion	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of