Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Depression

NCT ID: NCT06211140

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-05-31

Brief Summary

This study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18F-MPPF PET/MR, neuropsychological tests, and polysomnography (PSG) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tACS) for depressive disorders, mainly focusing on the serotonergic system revealed by Serotonin-1A (5-HT1A) receptor.

Detailed Description

5-HT1A receptor appears to be significantly involved in the effectiveness of electroconvulsive therapy (ECT). Like alternating current in ECT, tACS also applies alternating current to intervene in neuropsychiatric disorders. We previously found that tACS with large current, such as 15 mA, via the forehead and bilateral mastoids can improve depressive symptoms. However, the underlying mechanism of 15 mA tACS in depression remains unclear. We propose a scientific hypothesis that 15 mA tACS may increase hippocampal 5- HT1A receptors, then to reduce depression in depressive patients. Meanwhile, 15 mA tACS may increase the whole-brain functional connectivity with the hippocampus as the seed point. This study will utilize a multimodal data through 18F-MPPF PET/MR, including MPPF metabolism, resting-state fMRI, DTI, and 3D-T1 structural images. By observing the alterations of 5-HT1A receptor and the functional network between MDD patients and healthy controls, and between the pre- and post-tACS intervention in MDD patients, our aims to explore the effect of tACS on the serotonergic system in depression.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Depressive disorders

Three conductive electrodes will be placed overhead. Based on the 10/20 international placement system, a 4.45 x 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 x 3.81 cm electrodes are placed on the mastoid region of each side.

The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak).

All participants with major depression disorder will receive a total of 20 sessions in four weeks, once daily on weekdays, with tACS stimulation at 77.5 Hz and 15 mA.

From Monday to Friday, each session will last 40 min at a fixed daytime interval.

Group Type: EXPERIMENTAL

tACS

Intervention Type: DEVICE

tACS in 4 weeks, once per weekday for 40 minutes each, 20 sessions. The treatment group will receive transcranial alternating current stimulation at a gamma frequency (77.5Hz) with a peak amplitude of 15mA.

Healthy controls

Without the tACS stimulation in this group

Group Type: OTHER

Control

Intervention Type: OTHER

Without the tACS stimulation in this group.

Interventions

tACS

tACS in 4 weeks, once per weekday for 40 minutes each, 20 sessions. The treatment group will receive transcranial alternating current stimulation at a gamma frequency (77.5Hz) with a peak amplitude of 15mA.

Intervention Type: DEVICE

Control

Without the tACS stimulation in this group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. To undergo PET/MR examinations.

2. Be matched with the patient group regarding age, sex, and educational level.

Exclusion Criteria

1. Unable to do PET/MR examinations.

2. Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.

3. Severe or unstable organic diseases.

4. Pregnant or lactating women or those planning a pregnancy in the near future.

5. Alcohol or substance dependence or abuse within the past year.

6. Received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment.

7. Skin damage at the electrode placement site or those allergic to electrode gel or adhesives.

8. Participated in any other clinical trials within the month before baseline.

9. Any inappropriate conditions considered by the study group.

1. Those who are enrolled in other clinical studies.

2. The inappropriate conditions considered by the study group.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenfeng Zhao, MD

Role: CONTACT

fengfeng_zw@ccmu.edu.cn

+8613051118863

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+861083198650

Facility Contacts

Wenfeng Zhao, MD

Role: primary

fengfeng_zw@ccmu.edu.cn

+8613051118863

Other Identifiers

tACS-MDD

Identifier Type: -

Identifier Source: org_study_id