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.

Obsessive-Compulsive Disorder

Tic Disorders

Tourette Syndrome

5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting

Ondansetron

Placebo

New York University School of Medicine

The Nathan S. Kline Institute for Psychiatric Research

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

Sensory phenomena scale, Minimum: 0, Maximum: 15, higher scores indicate more severe sensory phenomena

Change in brain activation as measured by % blood-oxygen-level dependent (BOLD) signal change in insula and sensorimotor cortex from baseline to 4 weeks

Using the Patient-Rated Inventory of Side effects, greater endorsement indicates more side effects

Data Sharing Plan The project will be registered and results reported on ClinicalTrials.gov. Neuroimaging data and associated files (e.g. behavioral response data generated during tasks) will be de-identified and provided for use by other researchers. De-identification will include removal of sensitive data from image file headers (e.g. name, date of birth). The anonymized final data set will be made available upon request, with an announcement on the lab website providing information on how to obtain the data. In addition, final data will be uploaded to an appropriate public database, such as the Open fMRI project, for broad availability. Data sharing will comply with local, state, and federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), as well as institutional policies and review

NYU Langone Health

National Institutes of Health (NIH)

Single dose of 8 mg ondansetron (crossover with single dose of placebo)

Single dose of 16 mg ondansetron (crossover with single dose of placebo)

Single dose of 24 mg ondansetron (crossover with single dose of placebo)

Brain Function

Healthy Adults

ondansetron

placebo

Icahn School of Medicine at Mount Sinai

The Effects of Ondansetron on Brain Function

On Day1, Functional magnetic resonance imaging (fMRI) will be done 90 minutes after drug or placebo ingestion to measure the blood oxygen level dependent (BOLD) signal in insula and somatosensory cortex.

At week 1, fMRI will be done 90 minutes after drug or placebo ingestion to measure the BOLD signal in insula and somatosensory cortex.

On Day1, fMRI will be done 90 minutes after drug or placebo ingestion to measure the BOLD signal across the whole brain.

At week 1, fMRI will be done 90 minutes after drug or placebo ingestion to measure the BOLD signal across the whole brain.

tic disorders/nauzea

Transcranial Alternating Current Stimulation Treating Post-stroke Depression

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

The Effects of Ondansetron on Brain Function

Nejúplnější databáze léčivých bylin podložená vědou