Post-stroke Depression Clinical Trial
Official title:
The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial
Post-stroke depression (PSD) is one of the most common complications after stroke, with a high prevalence. PSD can affect prognosis and rehabilitation of stroke, increase risks of mortality and suicide, and escalate the economic burden on individuals and society. Studies have shown that transcranial alternating current stimulation (tACS) can also be used to treat depression, insomnia and anxiety. So far, this stimulator has been approved by FDA. However, there have not been any reports on the use of tACS in the treatment of depression and PSD in China. In this trial, the efficacy and safety of the tACS will be assessed with the rigor methodology manner.
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
without stroke. Some therapeutic methods have shown to be effective for PSD, including
antidepressants, non-drug interventions, and combination therapies. However, pharmacological
agents not only show unwanted side effects, including nausea, diarrhea, fatigue, and
dizziness, but also produce high risk of hemorrhagic complications and stroke. Therefore, in
addition to antidepressants treating PSD, non-drug interventions have been proposed to treat
PSD. Until now, there are various physical techniques, including transcranial magnetic
stimulation, vagus nerve stimulation, transcranial direct current stimulation, transcranial
ultrasonic stimulation, etc. 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 tACS 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.
Therefore, the study is expected to verify the effect of Transcranial Alternating Current
Stimulation on patients with PSD in China and preliminarily explore the variations of gamma
and beta-oscillations and cognitive function for the intervention of PSD utilized by it.
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