Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03903068
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2019-04-03
Brief Title:
Transcranial Alternating Current Stimulation Treating Post-stroke Depression
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 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 brains 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None