In this study, the group is the treatment group. Patients are randomly assigned to participate, and patients will be given current parameters for setting time and flow.

In this study, the group is the control group. Patients are randomly assigned to participate, and patients will be given simulated electrical stimulation.

Post-stroke Depression

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.

NEXALIN ADI AC stimulator

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.

Pseudo-stimulator

The Official website of NEXALIN ADI AC stimulator

Xuanwu Hospital, Capital Medical University

Transcranial Alternating Current Stimulation Treating Post-stroke Depression

The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial

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).

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)

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.

the Barthel Index (BI) score is used to assess the activities of daily living (ranging from 0 to 100, higher scores indicate increased independence)

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"

The proportions of participants have improvements of 1, 2, and 3 in the CGI-Improvement.

The changes of participants on anxiety symptoms

The changes of participants on cognitive function assessed by MMSE

The changes of participants on cognitive function

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).

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.

to measure cognitive status of PSD by the repeatable battery for the assessment of neuropsychological status (RBANS) at baseline, week 4, and week 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.

Allen Song，MD & PHD

Vice Chief of Neurology Department

Xuanwu Hospital, Beijing

Experiment Group: (NEXALIN ADI AC stimulators) vs Mock Group(pseudo-stimulators). Both require the same appearance, all kinds of buttons, buttons, lights, switches, settings, etc. are the same, but the pseudo-stimulator can not release current.

The study is blind to participant, care provider, investigator, outcomes assessor. If a serious adverse event occurs, stop treatment immediately.

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Transcranial Alternating Current Stimulation Treating Post-stroke Depression

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