Transcranial Alternating Current Stimulation Treating Post-stroke Depression
Keywords
Abstract
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 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.
Dates
| Last Verified: | 07/31/2019 |
| First Submitted: | 04/02/2019 |
| Estimated Enrollment Submitted: | 04/02/2019 |
| First Posted: | 04/03/2019 |
| Last Update Submitted: | 08/08/2019 |
| Last Update Posted: | 08/12/2019 |
| Actual Study Start Date: | 08/14/2019 |
| Estimated Primary Completion Date: | 08/14/2020 |
| Estimated Study Completion Date: | 10/29/2020 |
Condition or disease
Intervention/treatment
Device: NEXALIN Stimulator Group
Device: Pseudo-Stimulator Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 Stimulator Group 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. | Device: Pseudo-Stimulator Group 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. A diagnosis of PSD is based on the "Depressive disorder due to another medical condition" of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 2. Age 18-70 years old, gender is not limited; 3. Right-handed; 4. More than 6 months after the onset of stroke; 5. The duration of depressive disorder persists for more than two weeks; 6. Having the Hamilton Depression Rating Scale 17-Item (HAMD-17) scores higher than 17 at baseline; 7. Absence of psychiatric disorder or family history of psychosis before stroke; 8. Has never taken antidepressants before enrollment; 9. Having the level of audiovisual for examinations required for the study; 10. Providing signed informed consent. Exclusion Criteria: 1. Patients with life expectancy < 6 months; 2. Severe or unstable organic diseases; 3. Acute brain injury and infection; 4. The impaired skin integrity at the electrode placement site or skin allergic to electrode gel or adhesive; 5. Active current suicidal intent or plan as shown by a score of ≥ 3 on the suicide item of HAMD-17; 6. Current participation in any other clinical trial,; 7. Prior exposure to all kinds of neuromodulation treatments (including electroconvulsive therapy, TMS, tDCS, etc); 8. Prior exposure to any implanted device in body (including a cochlear implant, cardiac pacemaker, an implanted device or metal in the brain); 9. A history of brain organic diseases (including seizures, hydrocephalus, and brain tumors); 10. Any situations the investigators believe that they are not suitable for this study. |
Outcome
Primary Outcome Measures
1. the proportion of participants having an improvement at week 8 [week 8]
Secondary Outcome Measures
1. The proportions of participants achieve an improvement in neurological function [weeks 4 and 8]
2. The proportions of participants achieve an improvement in independence [weeks 4 and 8]
3. The proportions of participants with a Barthel Index (BI) score of ≥ 90 [weeks 4 and 8]
4. The proportions of participants having severity levels [weeks 4 and 8]
5. CGI-Improvement (CGI-I) [weeks 4 and 8]
6. the Hamilton Anxiety Rating Scale (HAMA) [weeks 4 and 8]
7. the Mini-Mental State Examination (MMSE) [weeks 4 and 8]
8. the Montreal Cognitive Assessment (MoCA) [weeks 4 and 8]
9. the proportion of participants having an improvement at week 4 [week 4]
10. the changes of beta-and gamma-oscillations at weeks 4 and 8 [weeks 4 and 8]
11. the variations of cognitive status at weeks 4 and 8 [weeks 4 and 8]
12. the proportions of participants have an epileptic seizure at weeks 4 and 8 [weeks 4 and 8]
13. the proportions of participants who have symptoms in the treatment-emergent symptom scale (TESS) at weeks 4 and 8 [weeks 4 and 8]
