Transcranial Alternating Current Stimulation Treating Post-stroke Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03903068|
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-stroke Depression||Device: NEXALIN ADI AC stimulator Device: Pseudo-stimulator||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The study is blind to participant, care provider, investigator, outcomes assessor. If a serious adverse event occurs, stop treatment immediately.|
|Official Title:||The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial|
|Estimated Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||August 15, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Experimental: NEXALIN Stimulator Group
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.
Device: 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. 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.
Sham Comparator: Pseudo-Stimulator Group
In this study, the group is the control group. Patients are randomly assigned to participate, and patients will be given simulated electrical stimulation.
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.
- the proportion of participants having an improvement at week 8 [ Time Frame: 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).
- The proportions of participants achieve an improvement in neurological function [ Time Frame: weeks 4 and 8 ]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)
- The proportions of participants achieve an improvement in independence [ Time Frame: weeks 4 and 8 ]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 proportions of participants with a Barthel Index (BI) score of ≥ 90 [ Time Frame: weeks 4 and 8 ]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 proportions of participants having severity levels [ Time Frame: weeks 4 and 8 ]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"
- CGI-Improvement (CGI-I) [ Time Frame: weeks 4 and 8 ]The proportions of participants have improvements of 1, 2, and 3 in the CGI-Improvement.
- the Hamilton Anxiety Rating Scale (HAMA) [ Time Frame: weeks 4 and 8 ]The changes of participants on anxiety symptoms
- the Mini-Mental State Examination (MMSE) [ Time Frame: weeks 4 and 8 ]The changes of participants on cognitive function assessed by MMSE
- the Montreal Cognitive Assessment (MoCA) [ Time Frame: weeks 4 and 8 ]The changes of participants on cognitive function
- the proportion of participants having an improvement at week 4 [ Time Frame: 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).
- the changes of beta-and gamma-oscillations at weeks 4 and 8 [ Time Frame: 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.
- the variations of cognitive status at weeks 4 and 8 [ Time Frame: 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.
- the proportions of participants have an epileptic seizure at weeks 4 and 8 [ Time Frame: 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.
- the proportions of participants who have symptoms in the treatment-emergent symptom scale (TESS) at weeks 4 and 8 [ Time Frame: weeks 4 and 8 ]TESS will be assessed at weeks 4 and 8
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903068
|Contact: Haiqing Song, email@example.com|
|Contact: Zu Wangfirstname.lastname@example.org|
|Xuanwu Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100053|
|Contact: Haiqing Song, Doctor|
|Principal Investigator:||Haiqing Song, doctor||Xuanwu Hospital, Beijing|