tDCS for Multiple System Atrophy With Cerebellar Feature
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 09/07/2019 |
| Estimated Enrollment Submitted: | 09/15/2019 |
| First Posted: | 09/16/2019 |
| Last Update Submitted: | 09/15/2019 |
| Last Update Posted: | 09/16/2019 |
| Actual Study Start Date: | 09/30/2019 |
| Estimated Primary Completion Date: | 04/30/2020 |
| Estimated Study Completion Date: | 09/30/2020 |
Condition or disease
Intervention/treatment
Device: transcranial direct current stimulation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: tDCS (M1) The participants will be submit to tDCS applied over the motor cortex (M1) | |
| Active Comparator: tDCS (Cerebellar cortex) The participants will be submit to tDCS applied over the cerebellar cortex | |
| Sham Comparator: Sham stimulation The participants will be submit to sham stimulation |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change from International Cooperative Ataxia Rating Scale (ICARS) [per session: at baseline and within 30 minutes tDCS treatment completion]
Secondary Outcome Measures
1. Change from temporospatial parameters of gait [per session: at baseline and within 30 minutes tDCS treatment completion]
2. Change from posturography [per session: at baseline and within 30 minutes tDCS treatment completion]
