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Clinical Trial Summary

Post-stroke depression (PSD) is one of the most common post-stroke dysfunction, with a high incidence. PSD affects prognosis and disease rehabilitation, increases disease mortality and suicide risk, and aggravates the economic burden on individuals and society. Studies have shown that transcranial alternating current (TAC) can also be used to treat depression, insomnia and anxiety. So far, this stimulator has been approved by FDA and is widely used in clinical practice in North America. However, there have not been any reports on the use of this technology in the treatment of depression and post-stroke depression in China. In this study, the latest TACs technology was used to treat PSD, and the therapeutic effects and adverse reactions could be preliminarily observed.

Clinical Trial Description

Patients with post-stroke depression (PSD) have more dysfunction, poorer recovery outcomes, and higher morbidity and mortality in the first year after stroke onset than those patients who without stroke. Nowadays, although the safety of the drug has been greatly increased, the present antidepressants still exist some problems, such as treat for symptoms, not for the real reasons, need long-term or even lifelong treatment, the inefficiency of drug treatment for some patients is discontinuation, easy to relapse, and so on. Therefore, the emergence of non-drug treatment brings a good news for the treatment of depressive disorders. Until now, there are various physical techniques, including transcranial magnetic stimulation, vagus nerve stimulation, transcranial direct current stimulation, transcranial ultrasonic stimulation. They have been applied in the regulation of brain function. What these methods have in common is that they directly or indirectly affect brain regions associated with the onset of depression. Previous studies have shown that transcranial alternating current stimulation (TACs) is commonly used to relieve pain, and has also been used to treat conditions such as transient tic disorder and cluster headaches. In the brain, there are specific opioid receptors which are not independent, and they work together with the electro analgesic system. Patients treated for chronic pain had lower levels of endorphins in their cerebrospinal fluid.Theoretically, using transcranial electrical stimulation (TCES) can alleviate pain was caused by electrical stimulation to activate the brain's pain system (anti-nociceptive system), led to the beta-endorphin, serotonin and norepinephrine release.

In this study, the latest TACs technology will be used in the treatment of PSD, and the efficacy and adverse reactions of the treatment of depression, insomnia and anxiety could be preliminarily observed, and the efficacy and safety of NEXALIN ADI tac technology in the treatment of patients with post-stroke depression will be preliminarily evaluated. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03903068
Study type Interventional
Source Xuanwu Hospital, Beijing
Contact Haiqing Song, doctor
Phone 86-13701390976
Status Not yet recruiting
Phase N/A
Start date May 1, 2019
Completion date October 30, 2020

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