Efficacy and Safety of tACS for Depression: a Multicenter RCT Study
NCT ID: NCT06891326
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-10-08
2026-10-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control group
sham transcranial Alternating Current Stimulation
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
Treatment group
active tACS
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.
Interventions
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sham transcranial Alternating Current Stimulation
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
active tACS
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.
Eligibility Criteria
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Inclusion Criteria
2. Age ranges between 18 and 65 years;
3. HDRS-17 score equals to or above 8;
4. No medical history/Under stable antidepressant treatment in one month;
Exclusion Criteria
2. History of invasive brain surgeries;
3. Non-invasive neurostimulation treatments within 3 months;
4. Physical condition that may endanger patients' safety during the study.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Shandong Mental Health Center
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Locations
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Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240913
Identifier Type: -
Identifier Source: org_study_id
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