Transcranial Alternating Current Stimulation Treating Post-stroke Depression

NCT ID: NCT03903068

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2020-10-30

Brief Summary

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.

Detailed 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.

Conditions

Post-stroke Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

NEXALIN ADI AC stimulator

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Pseudo-stimulator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Pseudo-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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Allen Song，MD & PHD

Vice Chief of Neurology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiqing Song, doctor

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiqing Song, doctor

Role: CONTACT

songhq@xwhosp.org

86-13701390976

Zu Wang

Role: CONTACT

wangzu0606@126.com

86-13260189598

Facility Contacts

Haiqing Song, Doctor

Role: primary

References

Shen X, Liu M, Cheng Y, Jia C, Pan X, Gou Q, Liu X, Cao H, Zhang L. Repetitive transcranial magnetic stimulation for the treatment of post-stroke depression: A systematic review and meta-analysis of randomized controlled clinical trials. J Affect Disord. 2017 Mar 15;211:65-74. doi: 10.1016/j.jad.2016.12.058. Epub 2017 Jan 10.

Reference Type: BACKGROUND

PMID: 28092847 (View on PubMed)

Gabis L, Shklar B, Baruch YK, Raz R, Gabis E, Geva D. Pain reduction using transcranial electrostimulation: a double blind "active placebo" controlled trial. J Rehabil Med. 2009 Mar;41(4):256-61. doi: 10.2340/16501977-0315.

Reference Type: BACKGROUND

PMID: 19247545 (View on PubMed)

Wang H, Zhang W, Zhao W, Wang K, Wang Z, Wang L, Peng M, Xue Q, Leng H, Ding W, Liu Y, Li N, Dong K, Zhang Q, Huang X, Xie Y, Chu C, Xue S, Huang L, Yao H, Ding J, Zhan S, Min B, Fan C, Zhou A, Sun Z, Yin L, Ma Q, Baskys A, Jorge RE, Song H. The efficacy of transcranial alternating current stimulation for treating post-stroke depression: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Apr;99(16):e19671. doi: 10.1097/MD.0000000000019671.

Reference Type: DERIVED

PMID: 32311940 (View on PubMed)

Related Links

https://nexalin.com/

The Official website of NEXALIN ADI AC stimulator

Other Identifiers

10000001

Identifier Type: -

Identifier Source: org_study_id