The Treatment of Transcranial Alternating Current Stimulation(tACS)on Patients With Cerebellar Ataxia: A Randomized, Triple-blind, Parallel-controlled Study

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    First Affiliated Hospital of Fujian Medical University
Updated on 25 October 2022
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This is a longitudinal, triple-blind, randomized-controlled, prospective observational study assessing patients with cerebellar ataxia, including spinocerebellar ataxia type 3 (SCA3) and multiple system atrophy-cerebellar type (MSA-C), to examine the efficacy, safety, and tolerability of transcranial alternating current stimulation (tACS) for up to 3 months.


Transcranial alternating current stimulation (tACS) is a relatively recent method that noninvasively modulates brain oscillations, and can effectively stimulate deep brain regions, affect brain rhythm, increase neural plasticity, change neurotransmitter levels, and improve brain function. It is a comfortable, safe, effective, non-invasive, and easy-to-operate method, which means it has development potential in relevant medical fields. It has been approved by the FDA for clinically treating neuropsychiatric diseases.

This is a prospective, longitudinal, triple-blind, randomized-controlled, observational study designed to evaluate the efficacy, safety, and tolerability of tACS in patients of SCA3 and MSA-C in China. Based on typical guidelines, we will use the tACS paradigm (bilateral mandible as a place for active electrode stimulation electrode, and the inion for the return electrode). Subjects will be randomized into two groups, one receiving a 10-day (5 days/week for 2 weeks) treatment with real cerebellar tACS and the other receiving a sham stimulation. The patient's motor function, cognitive function, sleep, mental state, plantar pressure, electroencephalogram, and magnetic resonance imaging will be assessed before and after the intervention.

There will be a total of 4 visits. All patients receiving CB-tACS will be visited face to face at baseline, day 1, day 30, and day 90 after the treatment begins.

Condition Spinocerebellar Ataxia Type 3, Multiple System Atrophy-cerebellar Type
Treatment transcranial alternating current stimulation
Clinical Study IdentifierNCT05557786
SponsorFirst Affiliated Hospital of Fujian Medical University
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

for SCA3
Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3
SCA3 patients aged 18 - 80 years
Patients or their family members have informed consent to the study and signed relevant documents
The pre-study ataxia Assessment Score (SARA) ranged from 3 to 30
for MSA-C
Aged 30-80 years
Diagnosed as clinically determined (Established)MSA-C or clinically Probable MSA-C according to the latest MSA diagnostic criteria
No more than 4 years after diagnosis of MSA-C
Able to walk independently or with assistance
Have a life expectancy of at least 3 years
Women of childbearing age with MSA need to use contraceptive measures

Exclusion Criteria

Patients who have concomitant epilepsy
Patients with a serious cognitive disorder, behavioral disorder, or mental illness
Patients with a history of seizures, stroke, encephalitis, or other degenerative neurological diseases
Patients with a serious medical disease
Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, or moderate or more severe liver disease
Patients with uncontrolled high blood pressure or diabetes
History of head injury or neurosurgical interventions
History of any metal in the head (outside the mouth)
Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line), or any medical pumps
Patients who have taken other investigational products within 4 weeks before being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
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