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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05557786
Study type Observational
Source First Affiliated Hospital of Fujian Medical University
Contact Shi-Rui Gan, MD, PhD
Phone 0591-87982772
Email ganshirui@fjmu.edu.cn
Status Recruiting
Phase
Start date August 1, 2022
Completion date March 31, 2023

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