tDCS for Multiple System Atrophy With Cerebellar Feature

Multiple System Atrophy, Cerebellar Variant (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092556
• Other study ID #: 2018-10-010-002
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 2020

Study information

• Verified date: September 2019
• Source: Samsung Medical Center
• Contact: Jinyoung Youn
• Phone: 82-2-3410-0245
• Email: genian[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Multiple System Atrophy, Cerebellar Variant (Disorder)
• Shy-Drager Syndrome

Intervention

Device:
• transcranial 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from temporospatial parameters of gait	Gait parameters measured by GAITRite system	per session: at baseline and within 30 minutes tDCS treatment completion
Secondary	Change from posturography	Posturography measured by Pedoscan system	per session: at baseline and within 30 minutes tDCS treatment completion