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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. The three electrodes are placed in this way to enhance the performance of the Nexalin ADI device. When the device is activated, there will be a weak current passing through the forehead electrode and each mastoid electrode. The current intensity of Nexalin ADI treatment defaults to 15.00 mA and the duration defaults to 40 minutes. Both are preset to default parameters and cannot be changed.
When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. When the device is started, no current flows through the electrodes, but the instrument's operating procedures, parameter displays, and prompts are the same as for a real instrument.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGthe proportion of participants having an improvement at week 8
the proportion of participants having an improvement at week 8, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a ≥ 50% reduction from the baseline or clinical recovery (score ≤ 7).
Time frame: week 8
The proportions of participants achieve an improvement in neurological function
The improvement will be decided by a reduction of ≥ 50% or the total score of 0-1 in the National Institute of Health Stroke Scale (NIHSS) score (ranging from 0 to 42, higher scores indicate a more severe neurological deficit)
Time frame: weeks 4 and 8
The proportions of participants achieve an improvement in independence
measured by a modified Rankin Scale (mRS) over the trial (scores on this scale range from 0 to 6, with higher scores indicating more significant disability), and the improvement is defined as 0, 1, and 2 in mRS.
Time frame: weeks 4 and 8
The proportions of participants with a Barthel Index (BI) score of ≥ 90
the Barthel Index (BI) score is used to assess the activities of daily living (ranging from 0 to 100, higher scores indicate increased independence)
Time frame: weeks 4 and 8
The proportions of participants having severity levels
the Clinical Global Impression-Severity (CGI-S) is a 7-point scale ranging from 1 being "normal, not at all ill" to 7 being "among the most extremely ill patients"
Time frame: weeks 4 and 8
CGI-Improvement (CGI-I)
The proportions of participants have improvements of 1, 2, and 3 in the CGI-Improvement.
Time frame: weeks 4 and 8
the Hamilton Anxiety Rating Scale (HAMA)
The changes of participants on anxiety symptoms
Time frame: weeks 4 and 8
the Mini-Mental State Examination (MMSE)
The changes of participants on cognitive function assessed by MMSE
Time frame: weeks 4 and 8
the Montreal Cognitive Assessment (MoCA)
The changes of participants on cognitive function
Time frame: weeks 4 and 8
the proportion of participants having an improvement at week 4
the proportion of participants having an improvement at week 4, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a ≥ 50% reduction from the baseline or clinical recovery (score ≤ 7).
Time frame: week 4
the changes of beta-and gamma-oscillations at weeks 4 and 8
assessing the resting-state high-density EEG (rsHEEG) by utilizing a 128 channel EEG system (Geodesic EEG system 400, Electrical Geodesics, Inc., OR, USA) at baseline, week 4, and week 8.
Time frame: weeks 4 and 8
the variations of cognitive status at weeks 4 and 8
to measure cognitive status of PSD by the repeatable battery for the assessment of neuropsychological status (RBANS) at baseline, week 4, and week 8.
Time frame: weeks 4 and 8
the proportions of participants have an epileptic seizure at weeks 4 and 8
Electroencephalogram (EEG) of all patients will be recorded at baseline, week 4, and week 8. and the epileptic seizure will be verified by two independent experienced neurologists based on EEG activity and clinical manifestations.
Time frame: weeks 4 and 8
the proportions of participants who have symptoms in the treatment-emergent symptom scale (TESS) at weeks 4 and 8
TESS will be assessed at weeks 4 and 8
Time frame: weeks 4 and 8
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