The Treatment of Transcranial Alternating Current Stimulation（tACS）on Patients With Cerebellar Ataxia: A Randomized, Triple-blind, Parallel-controlled Study
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- STATUS
- Recruiting
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- days left to enroll
- 3
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- participants needed
- 164
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- sponsor
- First Affiliated Hospital of Fujian Medical University
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.
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.
Details
| Condition | Spinocerebellar Ataxia Type 3, Multiple System Atrophy-cerebellar Type |
|---|---|
| Treatment | transcranial alternating current stimulation |
| Clinical Study Identifier | NCT05557786 |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Last Modified on | 25 October 2022 |
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