Clinical trial NCT04092556: tDCS for Multiple System Atrophy With Cerebellar Feature
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)
Keywords: Multiple System Atrophy
Cerebellar Ataxia
Transcranial Direct Current Stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: per session: at baseline and within 30 minutes tDCS treatment completion
Secondary outcomes:
measure: Change from temporospatial parameters of gait
timeFrame: per session: at baseline and within 30 minutes tDCS treatment completion
measure: Change from posturography
timeFrame: per session: at baseline and within 30 minutes tDCS treatment completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Department of Neurology
name: Jinyoung Youn
role: PRINCIPAL_INVESTIGATOR
References: