Efficacy and Safety of tACS for Depression: a Multicenter RCT Study

NCT06891326 | Recruiting DMC

• 1 other identifier: 20240913
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Transcranial alternating current stimulation (tACS) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. Randomized controlled trials (RCTs) of depression treated by tACS have been conducted but provided limited and incongruous results. We designed a multi-center RCT to evaluate the efficacy and safety of tACS for depression. Eligible participants will be patients diagnosed with depression (HDRS-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. A total of 72 participants will be recruited from 4 clinic centers. Participants will be randomized 1:1 to active tACS or sham stimulation group. The study staff and the participants are blinded to the randomization results. Stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (DLPFC) using frequency of 10Hz and amplitude of 1.5 to 2.0 mA. The intervention will last for 4 weeks, containing 20 40-minute sessions in total. Another 4-week observation will be followed by the end of the intervention. Participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. Psychological scales are used for the evaluation of their mental and quality of life. Besides, electroencephalogram (EEG) recording and magnetic resonance imaging (MRI) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.

Conditions

Depression Disorders

Keywords

tACS; depression

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  The primary endpoint is defined as the decreased scores of Hamilton Depression Scale-17 (HDRS-17) at the 4-week follow-up compared to baseline scores. HDRS ranges from 0 to 68, with higher scores indicating more severe depression symptoms. The two-sample t-test is used to test the difference in score changes between the treatment group and control group at the 4-week follow-up visit point.

  4 weeks after the intervention

Secondary Outcomes (1)

• Adverse events

  8 weeks, when the study is completed

Study Arms (2)

Control group

SHAM COMPARATOR

Device: sham transcranial Alternating Current Stimulation

Treatment group

ACTIVE COMPARATOR

Device: active tACS

Interventions

sham transcranial Alternating Current Stimulation DEVICE

we use fade-in, short-stimulation, fade-out (FSF) stimulation pattern, with 60s-long fade-in/out periods, 2.0mA peak current at the beginning and the end of stimulation session

Control group

active tACS DEVICE

The active tACS protocol lasted for 40 min of continuous sine-wave stimulation with the frequency of 10Hz and an amplitude ranging from 1.5mA to 2.0mA, adjusted according to the tolerability among individuals.

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of depressive disorder;
• Age ranges between 18 and 65 years;
• HDRS-17 score equals to or above 8;
• No medical history/Under stable antidepressant treatment in one month;

You may not qualify if:

• Combination of other psychotic disorders and neurological diseases;
• History of invasive brain surgeries;
• Non-invasive neurostimulation treatments within 3 months;
• Physical condition that may endanger patients' safety during the study.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Mental Health Center: collaborator
• Shandong Mental Health Center: collaborator

Study Sites (2)

Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Yunhao Wu

CONTACT

008602115021638398; wuyh_2022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: March 24, 2025
• Study Start: October 8, 2024
• Primary Completion: September 8, 2025
• Study Completion (Estimated): October 8, 2026
• Last Updated: March 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (2)