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

NCT06211140 | Unknown

• 1 other identifier: tACS-MDD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression; tACS; 5-HT

Outcome Measures

Primary Outcomes (1)

• The changes in quantitative MPPF values before and after the tACS intervention.

  Twenty patients with depressive disorders will receive 18F-MPPF PET/MR imaging before and after the tACS intervention. MPPF metabolism values in different brain regions will be calculated. A comparative analysis will be then performed between the baseline and post-treatment in patients with depressive disorders.

  baseline (before the tACS intervention), 4 weeks (after the tACS intervention)

Secondary Outcomes (7)

• The changes in scores for 17-item Hamilton Depression Rating Scale (HAMD-17) before and after the tACS intervention.

  baseline, 4 weeks

• The changes in scores for Hamilton Anxiety Rating Scale (HAMA) before and after the tACS intervention.

  baseline, 4 weeks

• The changes in scores for Generalized Anxiety Disorder-7 item (GAD-7) before and after the tACS intervention.

  baseline, 4 weeks

• The changes in scores for Pittsburgh Sleep Quality Index (PSQI) before and after the tACS intervention.

  baseline, 4 weeks

• The changes in scores for Insomnia Severity Index (ISI) before and after the tACS intervention.

  baseline, 4 weeks

Study Arms (2)

Depressive disorders

EXPERIMENTAL

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.

Device: tACS

Healthy controls

OTHER

Without the tACS stimulation in this group

Other: Control

Interventions

tACS 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.

Depressive disorders

Control OTHER

Without the tACS stimulation in this group.

Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unable to do PET/MR examinations.
• Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.
• Severe or unstable organic diseases.
• Pregnant or lactating women or those planning a pregnancy in the near future.
• Alcohol or substance dependence or abuse within the past year.
• Received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment.
• Skin damage at the electrode placement site or those allergic to electrode gel or adhesives.
• Participated in any other clinical trials within the month before baseline.
• Any inappropriate conditions considered by the study group.
• To undergo PET/MR examinations.
• Be matched with the patient group regarding age, sex, and educational level.
• Those who are enrolled in other clinical studies.
• The inappropriate conditions considered by the study group.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Wenfeng Zhao, MD

CONTACT

+8613051118863; fengfeng_zw@ccmu.edu.cn

Hongxing Wang, MD & PhD

CONTACT

+861083198650; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment; Non-Randomized; Open-label

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 18, 2024
• Study Start: January 31, 2024
• Primary Completion: December 20, 2024
• Study Completion: May 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2023-12

Locations

CN (1)